Loading…
Monday, June 8
 

1:00pm EDT

12P : Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies
Monday June 8, 2026 1:00pm - 4:00pm EDT
TBD
Component Type: TutorialCE: ACPE 2.75 Knowledge UAN: 0286-0000-26-501-L04-P; IACET 2.75Pre-Registration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.This Short Course will be offered virtually – Join from anywhere!This short course on real-world evidence (RWE) in regulatory decision-making offers a comprehensive exploration of how RWE is...
See More →
Speakers
avatar for Jaclyn Bosco

Jaclyn Bosco

Vice President & General Manager, Global Head of Epidemiology & Scientific Strat, IQVIA, United States
Dr. Jaclyn Bosco Global Head of Epidemiology & Scientific Strategy in Real World Evidence at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated... Read More →
avatar for Kourtney Davis

Kourtney Davis

Vice President, Global Epidemiology at Janssen R&D, LLC, The Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Dr. Kourtney Davis is currently Senior Director and Therapy Area Matrix Lead for Global Epidemiology at Janssen R&D, where she leads a team of 20+ epidemiologists aligned to therapy areas (CNS, Immunology, CV/Met, Oncology, ID/Global Public Health/Vaccines, and Pulmonary Hypertension... Read More →
avatar for Linda Kalilani

Linda Kalilani

Executive Director and Head of Oncology Epidemiology, GSK, United States
Linda Kalilani is an Executive Director & Head of Oncology Epidemiology at GlaxoSmithKline. She has worked as an epidemiologist in the pharmaceutical industry for over 10 years. She has led the development of cross-functional real-world evidence strategies, has extensive experience... Read More →
avatar for Isha Riley

Isha Riley

Associate Director, Pharmacoepidemiololgy & Risk Management Implementation, Regeneron, United States
Isha Mehta Riley is an Associate Director of Pharmacoepidemiology and Risk Management at Regeneron Pharmaceuticals. She has extensive experience in post-authorization safety strategies, including real-world evidence generation and risk management activities to inform global regulatory... Read More →
Monday June 8, 2026 1:00pm - 4:00pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Tutorial |   10: Stats-EvidenceGeneration-RWE, Tutorial |   17: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, IACET
  • Tags Tutorial
 
Monday, June 15
 

8:00am EDT

#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures
Monday June 15, 2026 8:00am - 10:00am EDT
Ballroom AB
Component Type: SessionLevel: IntermediateThis opening plenary explores how patient driven science, AI enabled discovery, and regulatory innovation can uncover “hidden cures” in the medicines and data we already have. Through a keynote from David Fajgenbaum and a panel on AI in biopharma, the session asks how we can find, trust, and deliver tomorrow’s cures from today’s science.Learning...
See More →
Speakers
avatar for David Fajgenbaum

David Fajgenbaum

Co-Founder & President of Every Cure, Every Cure, United States
avatar for Audrey Greenberg

Audrey Greenberg

Mayo Clinic, Venture Partner and Chair, Mayo Ventures, United States
avatar for Rahul Gupta

Rahul Gupta

President, GATC Health, United States
Dr. Gupta was appointed President of GATC Health, a tech-bio company advancing drug discovery and development, in February 2025. He previously served as Director of the White House Office of National Drug Control Policy (ONDCP) from 2021 to January 2025—the first physician to lead... Read More →
DP

David Pfeiffer

SVP, Head of ARCAS, Bio-Tech, Acrisure Re, United States
avatar for Greg Sarafin

Greg Sarafin

Chief Administrative Officer, Sovereign AI, United States
Greg Sarafin is the Chief Administrative Officer of Sovereign AI where he oversees corporate functions, capital, partnerships, and vendors. Sovereign AI is a vertically integrated, country-first AI infrastructure and platform designed to support governments, regulated industries... Read More →
avatar for Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Monday June 15, 2026 8:00am - 10:00am EDT
Ballroom AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   00: Plenary, Session

10:00am EDT

#401 SCC: Student Case Competition
Monday June 15, 2026 10:00am - 11:00am EDT
Content Hub
Component Type: SessionEach year, DIA hosts a Student Case Competition at our Global Annual Meeting that provides students the opportunity to respond and propose viable solutions to current challenges faced throughout the drug development lifecycle. The competition will be judged by a committee of DIA Fellows and Esteemed Volunteers, who include our most experienced and engaged members that...
See More →
Speakers
avatar for Sorcha McCrohan

Sorcha McCrohan

Sr. Scientific Project Manager, DIA, United States
Sorcha McCrohan is a Senior Scientific Project Manager for Global Science at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics... Read More →
Monday June 15, 2026 10:00am - 11:00am EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  15: Networking-Opportunities, Session

10:15am EDT

#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 3
Component Type: SessionBiopharma organizations have spent decades generating clinical content. Trial master files, investigator documents, safety narratives, and regulatory submissions sit largely unclassified and functionally invisible across content repositories. Content was generated across every study, processed once, and never revisited — leaving every insight locked inside the document...
See More →
Speakers
avatar for Boris Braylyan

Boris Braylyan

Chief Digital & Data Officer, Parexel, United States
Boris Braylyan is a technology leader with over two decades of experience advancing digital innovation in regulated industries. His career spans large scale transformations in life sciences, including 20 years at Pfizer, where he modernized global clinical and regulatory systems and... Read More →
avatar for Box, Inc.

Box, Inc.

United States
avatar for Ali Shamoun

Ali Shamoun

Director, Global Development Systems, Regeneron, United States
avatar for Manu Vohra

Manu Vohra

Vice President and Managing Director, Life Sciences, Box, United States
Manu Vohra is the Global lead for Life Sciences and Go-To-Market strategy for Cloud Content Management at Box.com. After two decades deploying ECM solutions in a regulated industry, he's spending his efforts supporting Life Sciences companies to ride the Digital Transformation wave... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#401.2 IT: Deep Intelligent Pharma K.K. Innovation Theater: Accelerate Deep Tech Impact - Mentor Japanese MD/PhDs with Agentic AI from Startup Launch to Physician-Led Trials
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 2
Component Type: SessionJapanese MDs and PhDs possess deep tacit knowledge and clinical insights that could transform patient care, yet turning these into successful deep tech startups and physician-led clinical trials remains extremely challenging due to fragmented support systems, regulatory complexity, and limited entrepreneurial resources. This session introduces a powerful new approach that...
See More →
Speakers
DI
avatar for Shinya Yamamoto

Shinya Yamamoto

General Manager, Deep Intelligent Pharma ( Singapore) private limited, Japan
Shinya Yamamoto, PhD currently serves as GM of Deep Intelligent Pharma K.K., leading AI-driven innovation in drug development and clinical research. He is passionately committed to unlocking tacit knowledge from Japanese universities and medical institutions and transforming it into... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#401.3 IT: IQVIA Innovation Theater: Transforming Clinical Development - Harnessing AI for Predictive Simulation and Agentic Automation
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 1
Component Type: Session



Chair

IQVIA

Speaker

Speaker
Raja Shankar, MS


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Raja Shankar

Raja Shankar

VP, Machine Learning, IQVIA, United Kingdom
As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

11:00am EDT

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?
Monday June 15, 2026 11:00am - 12:15pm EDT
118AB
Component Type: ForumLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P; CME 1.25; RN 1.25This forum will see different stakeholders discussing what they consider as future priority areas for our vigilance activities and what data sources offer the greatest opportunities for delivering a bigger impact on patient care. Learning Objectives Describe the changes in availability and use of...
See More →
Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
AR

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Forum |   03: Data-Tech-AI, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Data Management & Data Standards
  • Tags Forum

11:00am EDT

#404: Evidence-Based Insights Informing Participant Compensation Strategies
Monday June 15, 2026 11:00am - 12:15pm EDT
108B
Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-512-L04-P; CME 1.25; RN 1.25This session presents findings from a DIA–Tufts CSDD study examining how participant compensation strategies vary across trial phases and therapeutic areas and their impact on recruitment, retention, and enrollment outcomes, with implications for protocol design and trial executionLearning...
See More →
Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for Sabina Kineen

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In this role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
ES

Elizabeth Smith Morris

Director, Product Management, Patient Engagement, Suvoda, United States
avatar for Brittany Niland

Brittany Niland

Senior Director- Patient Engagement, Recruitment, Diversity & Retention, Eli Lilly and Company, United States
Brittany Niland is Senior Director of Patient Engagement, Recruitment, Diversity & Retention, leading global, patient-centered recruitment and retention strategies across the Oncology portfolio. She focuses on expanding equitable access to clinical trials, accelerating enrollment... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

11:00am EDT

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution
Monday June 15, 2026 11:00am - 12:15pm EDT
108A
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-511-L04-P; CME 1.25; RN 1.25Clinical Operations leaders today are navigating one of the most dynamic periods in recent history. From managing AI-driven transformation to rethinking global outsourcing models and rebuilding teams in a post-layoff landscape, the challenges facing clinical operations executives are...
See More →
Speakers
avatar for Joe Dustin

Joe Dustin

Founder and Principal, Dauntless eClinical Strategies, United States
Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →
avatar for Joseph Dustin

Joseph Dustin

Founder and Principal, Dauntless eClinical Strategies, United States
Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →
RF

Rosalie Filing

Vice President, Clinical Operations, Keenova Therapeutics, United States
NA

Nikki Amaratunge, MA, PMP

Director Clinical Operations, Allergan, United States
avatar for Jennifer Sheller

Jennifer Sheller

Senior Vice President, Global Clinical Trial Operations, Merck & Co., Inc., United States
Jennifer Sheller is Senior Vice President and Head of Global Clinical Trial Operations at Merck, where she leads the global infrastructure responsible for the operational delivery of Merck’s clinical development portfolio. With more than 25 years of experience across pharma, biotech... Read More →
EW

Emily Walker

Vice President, Study Management, Alnylam, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Project Management & Strategic Planning
  • Tags Session

11:00am EDT

#405: AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment
Monday June 15, 2026 11:00am - 12:15pm EDT
109AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-514-L04-P; CME 1.25; RN 1.25AI offers promise in standardizing radiology and pathology by reducing inter-human variability. This session examines opportunities, risks, regulatory oversight, and the role of reference datasets for tool validation.Learning Objectives Describe the current landscape and practical...
See More →
Speakers
JB

Jason Binder

Founder & CEO, Ember, United States
Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →
avatar for Alain Silk

Alain Silk

Senior Director, Regulatory Affairs, Tempus AI, Inc., United States
Alain Silk is a Senior Director of Regulatory Affairs at Tempus AI, a technology company applying analytic tools to provide data driven insights from clinical and molecular data. Dr. Silk has over a decade of experience as a medical device regulatory professional across diverse diagnostic... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

11:00am EDT

#406: Enhancing Regulatory Collaboration through Cloud Technologies
Monday June 15, 2026 11:00am - 12:15pm EDT
111AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-513-L04-P; CME 1.25; RN 1.25The session will explore lessons learned and challenges in scaling up cloud-powered regulatory collaborations. It will feature insights from technology providers, regulatory agencies, and industry representativesLearning Objectives Explain the value of regulatory collaboration and describe...
See More →
Speakers
avatar for Ana Carolina Moreira Marino Araujo

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil
Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →
avatar for Marko Eric

Marko Eric

Regulatory Assessor, Medicines and Medical Devices Agency of Serbia , Serbia
Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Julie Lepin

Julie Lepin

Senior Vice President & Chief Regulatory Officer, BeOne Medicines, United States
Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum

11:00am EDT

#407: The Great Debate: Using AI in Patient-Facing Materials
Monday June 15, 2026 11:00am - 12:15pm EDT
105AB
Component Type: ForumLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-515-L04-P; CME 1.25; RN 1.25Artificial intelligence is influencing how pharmaceutical companies plan to develop patient-facing materials (promising faster production, improved readability, and more personalized education) —while also raising questions about accountability, empathy, trust, bias, and accuracy. In this...
See More →
Speakers
avatar for Kimbra Edwards

Kimbra Edwards

Senior Director, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP) , United States
Kim Edwards is the Senior Director of Health Communication Services at the Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is a non-profit organization focused on increasing awareness and understanding of clinical research participation. Kim oversees... Read More →
avatar for Irene Kuhlman

Irene Kuhlman

Global Labeling Strategist, Bayer, Netherlands
After obtaining her MSc in Biomedicine, Irene began her career in various science and health communication roles at non-profit organizations. She then transitioned to Regulatory Affairs, where she worked for 14 years as a local and EU Regulatory Manager at the Dutch Bayer affiliate... Read More →
avatar for Regina Lynn Preciado

Regina Lynn Preciado

VP, Content Strategy Solutions, Content Rules, Inc., United States
Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →
avatar for Christine Von Raesfeld

Christine Von Raesfeld

Board member/community liaison, The Light Collective, United States
Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   03: Data-Tech-AI, Forum
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
  • Feature Topics Artificial Intelligence
  • Tags Forum

11:00am EDT

#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics
Monday June 15, 2026 11:00am - 12:15pm EDT
116
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-516-L04-P; CME 1.25; RN 1.25In this session, we will address the challenges of conducting clinical research in Europe under IVDR and CTR, and explore stakeholder-proposed solutions. We will also discuss the evolving regulatory landscape for combined clinical trials.Learning Objectives Explain the key principles...
See More →
Speakers
avatar for Joshua Levin

Joshua Levin

Director, Global Regulatory Affairs, Precision Medicine and Digital Health, GSK, United States
MM

Martin Mengel

Federal Institute for Drugs and Medical Devices, Germany
avatar for Rolf Thermann

Rolf Thermann

Section Manager IVD, Companion Diagnostics lead, TÜV Rheinland, Germany
Rolf Thermann is currently Auditor and Technical Expert with a focus on Companion Diagnostics at TÜV Rheinland LGA Products GmbH. Before joining TÜV Rheinland in 2018 he worked in the Pharmaceutical Industry involved in Antiviral Drug Discovery and as a Head of Product Development... Read More →
avatar for Lauren Tobe

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →
avatar for Ana Trullas

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands
Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

11:00am EDT

#410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical
Monday June 15, 2026 11:00am - 12:15pm EDT
202AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-517-L04-P; CME 1.25; PDU 1.25 PMI 216647VJP8; RN 1.25What if every investment were assessed for impact - before committing resources? As portfolio decisions in R&D and Medical Affairs are becoming increasingly complex, leadership teams often struggle to link individual projects to overall portfolio performance....
See More →
Speakers
avatar for Robin Boss

Robin Boss

VP, Business Transformation, Campana & Schott, United States
Robin Boss is Vice President of Business Transformation Consulting at Campana & Schott, where he leads a U.S. team working with Life Sciences organizations on large-scale pharma transformation programs. His focus is on portfolio and project management as a core lever to implement... Read More →
avatar for Jill Orosz

Jill Orosz

Vice President, TKI Franchise Head, Bayer, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Interest Area Project Management & Strategic Planning
  • Tags Workshop

11:00am EDT

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI
Monday June 15, 2026 11:00am - 12:15pm EDT
203AB
Component Type: SessionLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P; CME 1.25; PDU 1.25 PMI 216641I1NS; RN 1.25In this session, we will focus on the evolving role of the quality assurance professional, show you how to manage your professional development as a project, and build skills to deliver measurable outcomes in the age of AI.Learning Objectives Recognize the evolving role...
See More →
Speakers
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
JJ

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States
Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →
avatar for Michael Pelosi

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
HV

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States
Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session |   09: RD-Quality-Compliance, Session
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Interest Area Health Technology & AI,Quality Assurance / Control & CMC
  • Feature Topics Artificial Intelligence
  • Tags Session

11:00am EDT

#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Monday June 15, 2026 11:00am - 12:15pm EDT
118C
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-519-L04-P; CME 1.25; RN 1.25The recent focus by the US government to increase US-based pharmaceutical manufacturing has created opportunities to revisit the regulations and guidelines that lead to the lengthy time that it takes to construct or expand a manufacturing facility.Learning Objectives Discuss critical...
See More →
Speakers
avatar for John Balchunas

John Balchunas

Workforce Director, National Institute for Innovation in Manufacturing Biopharma, United States
John Balchunas is the Workforce Director for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) where he is responsible for guiding strategy around workforce and talent development for a federally-funded public private partnership focused on transforming... Read More →
JK

Joseph Kutza

Senior Director Regulatory Policy - CMC, Eli Lilly and Company, United States
Currently Senior Director Global Regulatory Policy and Strategy - CMC at Lilly. Focus on global regulatory policy and external engagement for all product types. Formerly in Regulatory Affairs CMC at AstraZeneca and a reviewer of monoclonal antibodies at the FDA. Ph.D. in Immunology... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Lisa Wright

Lisa Wright

Director Regulatory Policy, Novo Nordisk A/S, United States
Lisa Wright brings over a decade of experience in the pharmaceutical and biopharmaceutical industry. She has held multiple positions with a primary focus on regulatory affairs and policy. In her current role at Novo Nordisk, Lisa engages with the FDA on regulatory CMC and device issues... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

11:00am EDT

#415: Regulatory Cooperation Between the United States and Japan
Monday June 15, 2026 11:00am - 12:15pm EDT
115C
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-522-L04-P; CME 1.25; RN 1.25This session provides an update on the current regulatory affairs between FDA and PMDA. Both agencies will highlight significant regulatory collaboration in two areas, oncology and drug safety and discuss future regulatory activities in their region.Learning Objectives Describe the latest...
See More →
Speakers
avatar for Mark Abdoo

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States
avatar for Sema Hashemi

Sema Hashemi

Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
avatar for Miki Ota

Miki Ota

Director, Office of Informatic and Manegement for Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Miki Ota joined the MHLW in December 2000, when she was assigned to the Pharmaceutical and Food Safety Bureau. She was mainly involved in Safety measure of Chemical Substance. Subsequently, she worked in several organizations including Ministry of the Environment, National Personnel... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

11:00am EDT

#416.1: International Regulatory Cooperation with the African Medicines Agency
Monday June 15, 2026 11:00am - 12:15pm EDT
110A
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-608-L04-P; CME 1.25; RN 1.25A 60-minute session with AMA, FDA, and partners will review successes in collaboration, explore future opportunities to enhance oversight and access, and conclude with interactive Q&A on advancing harmonized regulatory systems in Africa.Learning Objectives Discuss the FDA priorities in...
See More →
Speakers
EB

Emile Bienvenu

Director General, Rwanda Food and Drug Authority, Rwanda
avatar for Delese Mimi Darko

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →
HG

Heran Gerba

Director General, Ethiopian Food and Drug Authority (EFDA), Ethiopia
AM

Ahmed Mohamed

Chief Executive Officer, Pharmacy and Poisons Board, Kenya
avatar for Meisha Sampson

Meisha Sampson

Director, FDA, United States
Meisha Sampson is the inaugural Director of the FDA African Medicines Agency Liaison Office within FDA’s Office of Global Policy and Strategy, based at the U.S. Embassy in Kigali, Rwanda, home to the African Medicines Agency. In this role, she advances a collaborative FDA–AMA... Read More →
AS

Aissatou SOUGOU

Director General, Department of Pharmacy and Laboratories (DPL) , Senegal
Monday June 15, 2026 11:00am - 12:15pm EDT
110A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

11:00am EDT

#416: Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact
Monday June 15, 2026 11:00am - 12:15pm EDT
204AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-524-L04-P; CME 1.25; RN 1.25This session presents insights from the Women’s Health Innovation Radar, highlighting global evidence gaps and emerging research priorities. It explores strategic and policy implications to accelerate scientific and clinical progress in women’s health.Learning Objectives Identify key...
See More →
Speakers
avatar for Victoria DiBiaso

Victoria DiBiaso

Head of Patient Informed Development & Health Value Translation, Sanofi, France
Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
avatar for Martin Hodosi

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United States
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
avatar for Katherine Senter

Katherine Senter

Assistant Director, Cancer Clinical Research Operations, Sidney Kimmel Cancer Center – Jefferson Health, United States
Katherine Senter, MPH, CCRP currently serves as Assistant Director for Cancer Clinical Research Operations at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Jefferson. Here she guides Clinical Research Managers, Investigators, and their teams to conduct and streamline high... Read More →
avatar for Sanj Singh

Sanj Singh

CEO, Temple Therapeutics, Netherlands
He is a biotech leader with 20+ years of driving innovation and growth. As co-founder and CEO of Temple Therapeutics, he has built a clinical-stage company at the forefront of women’s health—advancing a differentiated pipeline, securing strategic partnerships, expanding IP, and... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

11:00am EDT

#413: Health Canada Town Hall
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P; CME 1.25; RN 1.25In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.Learning Objectives Describe Health Canada’s regulatory initiatives and strategic priorities; Identify...
See More →
Speakers
avatar for Alysha Croker

Alysha Croker

Director, Strategic and Horizontal Policy, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
avatar for Sophie Sommerer

Sophie Sommerer

Director General, Marketed Health Products Directorate, Health Canada, Canada
Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

11:00am EDT

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Monday June 15, 2026 11:00am - 12:15pm EDT
115AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.Learning Objectives Describe the user-fee...
See More →
Speakers
avatar for Jeffrey Francer

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States
Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →
CP

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States
BT

Barrett Tenbarge

Partner, Faegre Drinker, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   06: ProfDevelop-Program-PortfolioMgmt, Forum

11:00am EDT

#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB
Component Type: ForumLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25This session aims to provide a comprehensive analysis of the FDA's practice of publicly posting CRLs. We will examine the past year's data, identify emerging trends, and assess the implications of this transparency initiative. Learning Objectives Discuss FDA's process for issuing and publicly...
See More →
Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
avatar for Amanda Conti

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States
EG

Eric Gascho

Vice President, CRD Associates, United States
Eric is a Vice President at CRD Associates and the Executive Director of the Coalition for Health Funding, positions he has held since 2024. He has extensive experience in a variety of legislative and regulatory policy issue areas, including federal budget and appropriations, public... Read More →
avatar for Eva Temkin

Eva Temkin

Partner, Arnold & Porter, United States
A partner in Arnold & Porter's Life Sciences and Healthcare practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

11:00am EDT

#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy
Monday June 15, 2026 11:00am - 12:15pm EDT
117
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P; CME 1.25; RN 1.25This session will provide a practical, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically, centered on Critical to Quality (CtQ) factors, demonstrating how to build a unified quality strategy that aligns with...
See More →
Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →
avatar for sumitra_sachidanandan

sumitra_sachidanandan

Regulatory Consultant - GCP Unit, Health Sciences Authority, Singapore
Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH... Read More →
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche, United Kingdom
Paula Walker is the Global Head of Risk-Based Quality Management (RBQM) at Roche and a member of the Quality Management Leadership team. As former Head of Compliance & Inspectorate at the MHRA, she brings over 13 years of regulatory experience to her mission of accelerating patient... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum |   02: ClinicalTrialOps-Innovation, Forum

12:15pm EDT

#418 POS: Student Poster Session I
Monday June 15, 2026 12:15pm - 2:15pm EDT
Exchange
Component Type: Session

Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
avatar for Kush Amin

Kush Amin

PharmD Candidate, Fairleigh Dickinson University, United States
Kush Amin is a PharmD candidate at Fairleigh Dickinson University College of Pharmacy & Health Sciences with a research focus in pharmacovigilance, managed care pharmacy, and real-world evidence generation. His work examines the intersection of drug safety, regulatory policy, and... Read More →
avatar for Evgeniia Artamonova

Evgeniia Artamonova

Master student, Technical University of Munich, Germany
Evgeniia Artamonova is a Master's student in Health Sciences (Health Prevention and Promotion) at the Technical University of Munich (TUM). She holds a degree in General Medicine (MD) and has a background in epidemiology, global health, biostatistics, and clinical research. Her Master's... Read More →
avatar for Faith Butta

Faith Butta

MS Clinical Research and Product Development, University of North Carolina Wilmington, United States
Faith Butta is a consultant who specializes in federally funded programs in regulatory compliance, program management, and programmatic cross-functional coordination. She has spend the past decade focusing on stakeholder engagement, data integrity, and process improvement. With her... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witwatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
TE

TEST Eisenhower

Sr. Exhibit, Sponsorship and Relationship Manager, DIA, United States
avatar for Ellie Froslan

Ellie Froslan

Student, University of Southern California, United States
Ellie Froslan is an undergraduate student at the University of Southern California pursuing a B.S. in Biopharmaceutical Sciences with a minor in Consumer Behavior, alongside a progressive M.S. in Healthcare Decision Analysis. She is a student researcher at the D.K. Kim International... Read More →
MG

Mansi Gupta

none, None, United States
Mansi Gupta is an MS Regulatory Affairs candidate at Northeastern University, Boston, MA, with a bachelor's in Biotechnology Engineering and 2+ years of experience working in QMS and regulatory compliance. At Tolmar Inc., she managed CAPA, deviations, change control, and document... Read More →
avatar for Jackson Hanf

Jackson Hanf

Student, University of Southern California, United States
Jackson Hanf is a B.S./M.S. candidate in Biochemistry and Management of Drug Development at the University of Southern California, where he conducts research in regulatory science and drug development. His work includes building data-driven tools to analyze facilitated regulatory... Read More →
avatar for Alex Juma Ismail

Alex Juma Ismail

PhD Student, University of Hertfordshire, United Kingdom
10+ years in African medicines regulation across national authorities, industry, and harmonisation. Led AUDA-NEPAD’s AMRH pilots on regulatory strengthening & harmonised frameworks. Currently Technical Officer at African Medicines Agency (AMA), supporting continental regulatory... Read More →
avatar for Ali Al Juboori

Ali Al Juboori

Medical Science Liaison, Azurity Pharmaceuticals, United States
TK

TzuYuan Kao

Student, University of Washington, United States
MK

Meghana Karnaty

masters in regulatory affairs, Northeastern University, United States
My name is Meghana Karnaty, and I am currently pursuing a Master of Science in Regulatory Affairs at Northeastern University in Boston, with a concentration in Clinical Research. My academic and professional journey has been shaped by a strong interest in healthcare, patient safety... Read More →
avatar for Bahar Lakeh

Bahar Lakeh

Student, Georgetown University School of Medicine, United States
avatar for Cezar Jr. Manansala

Cezar Jr. Manansala

Student, Centro Escolar University, Philippines
I am a registered Pharmacist who is in his last term of his Master of Science in Pharmacy Degree. I am a consultant to pharmaceutical and medical device companies in Japan. I am very passionate about research and would be very happy to collaborate with different organizations, profit... Read More →
JM

Julia Mauro

Project Specialist, DIA, United States
SP

Shreena Patel

Student Researcher, Massachusetts General Hospital, United States
avatar for Alex Raju

Alex Raju

Founder & Lead Researcher, Chatmedsafe | MS Candidate, LIU, United States
Alex Raju, PharmD, is a Pharmacovigilance (PV) scientist and researcher at the forefront of AI governance and global patient safety. Completing an MS in Drug Regulatory Affairs at Long Island University (LIU), his work leverages 8+ years of industry experience to focus on the compliant... Read More →
avatar for Ekaterina Shipilova

Ekaterina Shipilova

PhD Candidate, The Wistar Institute/The University of Bologna, United States
I am a PhD candidate at the Wistar Institute/University of Bologna joint program. I am a graduate of Pharmaceutical Biotechnology. Previously, I acquired a Bachelor's Degree in the Department of Natural Sciences, with a Major in Biology, a Minor in Physiology, and a thesis in Neurosciences... Read More →
avatar for Yuma Tsuboi

Yuma Tsuboi

PhD student, Waseda Univercity, Japan
Yuma Tsuboi is a regulatory science researcher and doctoral candidate at Waseda University's Cooperative Major in Advanced Biomedical Science. Regulatory science mediates three forces: translating cutting-edge technologies into measurable standards, enhancing predictability for safe... Read More →
avatar for ZIYU YE

ZIYU YE

Graduate Student, University of Macau, China
Ziyu Ye is a second-year master’s student in Medicinal Administration at the University of Macau. She received her bachelor’s degree from The Chinese University of Hong Kong, Shenzhen in 2024. With an interdisciplinary background, her research lies at the intersection of biomedical... Read More →
Monday June 15, 2026 12:15pm - 2:15pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session

12:25pm EDT

#419 IT: AlphaLife Sciences Innovation Theater: AI-Powered eCTD Authoring - Faster Draft-to-Submission with AI Tool Demos
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: SessionThis session explores practical, systematic approaches to AI-orchestrated authoring and quality control across the end-to-end R&D document lifecycle. We examine high-value use cases spanning clinical (Protocol, CSR, M2.5, M2.7), CMC, and nonclinical documentation to demonstrate how AI can drastically accelerate IND, NDA, and BLA filing timelines by shortening the...
See More →
Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen founded AlphaLife Sciences to bring enterprise-grade AI to drug development—specifically to the complex, compliance-driven world of regulatory and clinical authoring. She brings over 30 years of software engineering leadership experience, including roles as Asia Pacific... Read More →
avatar for William Chen

William Chen

Principal Business Solution Architect, AlphaLife Sciences, United States
Will Chen is Head of Solutions at AlphaLife Sciences, where he leads the design and deployment of AI-driven solutions to transform clinical development and life sciences workflows. He specializes in translating complex scientific and regulatory challenges into scalable, commercially... Read More →
avatar for AlphaLife Sciences
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#420 IT: CGS Immersive Innovation Theater: From 12 Weeks to 6 - How AI Transformed Compliance Training
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 3
Component Type: SessionThe biggest barrier in regulated training isn’t delivery — it’s the painstaking process of development. In this live session, see how Cicero Learn, an AI engine built for compliance-driven organizations, automatically transforms SOPs, protocols, and SME interviews into fully structured, audit-ready training — no templates or instructional designers needed. You’ll...
See More →
Speakers
CI

CGS Immersive

United States
avatar for Micah White

Micah White

VP, Research & Development, CGS Immerive, United States
Micah White leads R&D at CGS Immersive, where he applies augmented reality, mixed reality, and generative AI to transform learning and performance in highly regulated environments. He directs the development of platforms such as TeamworkAR™ and Cicero — turning complex SOPs, protocols... Read More →
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:50pm EDT

#421 CH: From Siloed Data to AI Ready Insights: How HL7 FHIR Enables Health Authority Ready Interoperability
Monday June 15, 2026 12:50pm - 1:20pm EDT
Content Hub
Component Type: WorkshopLevel: IntermediateThis session explores how to prepare data for AI and regulatory expectations through interoperable architectures with HL7 FHIR. Attendees will discuss how to make their own data reusable, trustworthy, and ready for tomorrow’s regulatory requirements.Learning Objectives • Show how the life sciences industry is using modern technology and HL7 FHIR to...
See More →
Speakers
JC

Joan Cheung

Principal Consultant, Epista Life Science, United States
Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs... Read More →
Monday June 15, 2026 12:50pm - 1:20pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

1:00pm EDT

#422 RT: Roundtable Discussion: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone B
Component Type: SessionLevel: IntermediateJoin the Regulatory Affairs Community for a follow up round table discussion tied to session: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts (Monday, June 15 | 1:00pm - 2:00pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Jude Nwokike, MPH, MSC,...
See More →
Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:00pm EDT

#423 RT: Roundtable Discussion: Enhancing Regulatory Collaboration through Cloud Technologies
Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone A
Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Enhancing Regulatory Collaboration through Cloud Technologies (Monday, June 15 | 1:00pm - 2:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Khushboo Sharma, MBA

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:05pm EDT

#424 IT: Kivo Innovation Theater: Nothing Changes Unless We Do - Implementing QMS with CRISPR Therapeutics in 52 Days
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2
Component Type: SessionQuality improvement rarely starts with a blank slate — but what happens when it does? When CRISPR Therapeutics faced a contract deadline and an overly complex QMS, they chose disruption over incremental fixes, rebuilding their Quality processes from the ground up in just 52 days. In this session, CRISPR's Executive Director of Quality and Pharmacovigilance Operations, Kate...
See More →
Speakers
avatar for Kate Ellmer

Kate Ellmer

Exec. Director, Quality and PV Operations, CRISPR Therapeutics, United States
Kate Ellmer is an Executive leader at CRISPR Therapeutics where she is responsible for Quality and Pharmacovigilance Operations. In her twenty-year industry career, she has explored her passion for implementing QMS and GxP systems that enable seamless business processes. Kate has... Read More →
KI

Kivo, Inc.

United States
avatar for Chris Xistris

Chris Xistris

Vice President of Services, Kivo, United States
Chris Xistris has 25+ years in Life Sciences, starting in Regulatory and Clinical Operations at small and mid-size biotechs. He then moved into consulting, building regulatory operations infrastructure for mid-size clients. Before joining Kivo, he spent over a decade at a Life Sciences... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

#425 IT: Parexel Innovation Theater: The Connected Submission - How AI, Automation, and Intelligence are Changing the Regulatory Ecosystem
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: SessionExplore how AI enabled authoring is transforming regulatory content development, delivering measurable improvements in speed, consistency, and quality across submissions. Discuss how process standardization serves as the critical enabler for automation, supporting faster, more scalable submission execution. Understand how connecting authoring, standardization, and automation...
See More →
Speakers
avatar for Katie Connelly

Katie Connelly

SVP, Global Head of Regulatory Affairs, Parexel International, United States
Katie, a senior leader at Parexel, brings extensive experience in designing, implementing, and delivering regulatory programs, with deep expertise in product leadership and change management. She oversees global regulatory affairs and operations outsourcing, regulatory FSP, submissions... Read More →
avatar for Parexel

Parexel

United States
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

Google Cloud Innovation Theater: Accelerating Discovery: The Shift to Agentic Research Workflows with Google’s Co-Scientist
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 3
Component Type: SessionIn a secure Gemini Enterprise environment, Google’s Co-Scientist uses multi-agent systems to accelerate breakthroughs by bridging digital data and biological insights, enabling high-velocity "Design-Test-Refine" cycles.Learning Objectives In a secure Gemini Enterprise environment, Co-Scientist provides frictionless enablement of scientific processes via a...
See More →
Speakers
avatar for Volker Eyrich

Volker Eyrich

Customer Engineer, AI Infrastructure, Google Cloud, United States
Volker Eyrich, PhD, is a Customer Engineer at Google Cloud where he focuses on the areas of Scientific Research as well as Scientific Computing. He joined Google in 2018. Prior to Google he spent 18 years in Computational Drug Discovery focusing on algorithm and infrastructure development... Read More →
avatar for David Henderson

David Henderson

AI Customer Engineer, Life Sciences, Google Cloud, United States
David Henderson, PhD, is a Customer Engineer at Google Cloud within the Healthcare and Life Sciences industry team. He specializes in the application of advanced AI and high-performance computing to accelerate drug discovery and scientific research. David has played a key role in... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:15pm EDT

#426 SS: Spark Stage: One Small Change
Monday June 15, 2026 1:15pm - 1:45pm EDT
Spark Stage
Component Type: SessionThis session challenges a core assumption in clinical operations: that “more technology” drives progress. Instead, it introduces a single, high-impact shift—moving from connected systems to embedded, site-centric workflows. By aligning technology with how sites actually work, rather than forcing sites to adapt to fragmented tools, organizations can reduce operational...
See More →
Speakers
avatar for Catherine Gregor

Catherine Gregor

Chief Clinical Trial Officer, Florence Healthcare, United States
Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide... Read More →
Monday June 15, 2026 1:15pm - 1:45pm EDT
Spark Stage The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  11: Spark Stage, Session

1:30pm EDT

#427 CH: Develop Regulatory CMC Strategies to Mitigate Global Drug Shortages Risks for Marketed Drug Products
Monday June 15, 2026 1:30pm - 2:00pm EDT
Content Hub
Component Type: WorkshopLevel: AdvancedDevelop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed productsLearning Objectives Benchmark key drivers for assessing supply- and demand-related risks that may lead to drug shortages. Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products. Apply risk-based...
See More →
Monday June 15, 2026 1:30pm - 2:00pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

1:45pm EDT

#427.1 SS: Spark Stage: Solve the Funding Paradox - Deploy Capital Smarter to Turn Promising Drug Candidates into Therapies
Monday June 15, 2026 1:45pm - 2:00pm EDT
Spark Stage
Component Type: SessionAs biomedical science grows more sophisticated, the number of drug development pathways is multiplying exponentially — yet most biopharma companies still deploy capital using strategies that fail to account for this complexity. The result: good science lost to bad finance. This session introduces a quantitative framework for biotech portfolio optimization, combining Monte...
See More →
Speakers
SC

Shomesh Chaudhuri

Co-Founder, QLS Technologies LLC, United States
Dr. Shomesh E. Chaudhuri is a Co-Founder of QLS Technologies. He's developed portfolio intelligence platforms for several biopharma companies, consulting directly with CEOs, CFOs, and their staffs to help align their financing structures with their scientific and medical objectives... Read More →
Monday June 15, 2026 1:45pm - 2:00pm EDT
Spark Stage The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  11: Spark Stage, Session

1:45pm EDT

#428 IT: Evernorth Health Services Innovation Theater: Enabling Real World Patient Reported Outcomes Collection Through Specialty Pharmacy Engagement
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 3
Component Type: SessionPatient-reported outcomes (PROs) are increasingly central to understanding real-world treatment experiences, yet recruiting patients into longitudinal PRO studies remains operationally challenging. Specialty pharmacies represent a high-frequency, trusted point of contact with patients receiving complex therapies, offering a scalable and underutilized opportunity for patient...
See More →
Speakers
avatar for Krystyna Amalfe

Krystyna Amalfe

Sr. Account Executive, Intelligence Solutions, Evernorth Health Services, United States
Krystyna Amalfe, MPH, is a public health professional with over 15 years of experience across clinical research, real world evidence, pharmaceutical lifecycle strategy, pharmacy benefit management, and payer markets. At Evernorth Health Services, she works at the intersection of data... Read More →
avatar for Evernorth

Evernorth

United States
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:45pm EDT

#429 IT: Verily Health Inc Innovation Theater: Bridge the Evidence Gap - Integrating Consumer Wearables and Real-World Data for Continuous, Participant-Centric Insights
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 1
Component Type: SessionLife sciences sponsors invest heavily in clinical trials, yet frequently lose visibility into patient outcomes the moment a study ends. While traditional real-world data attempts to bridge this gap, it relies on episodic snapshots that miss the continuous health signals that matter most: functional status and quality of life, reflected in sleep quality, daily physical...
See More →
Speakers
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Verily Health, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers and Science Innovation at Verily Health, where she leads research and evidence generation for digital health technologies. She oversees the development and implementation of AI/ML-enabled capabilities across clinical programs... Read More →
V

Verily

United States
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

2:30pm EDT

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV
Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P; CME 1.00; RN 1.00The CIOMS Working Group XIV, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance, transparency, robustness, fairness, and regulatory expectations using real examples.Learning Objectives Recognize common...
See More →
Speakers
avatar for Niklas Noren

Niklas Noren

Chief Science Officer, Uppsala Monitoring Centre, Sweden
Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily... Read More →
avatar for Beth MacEntee Pileggi

Beth MacEntee Pileggi

Senior Director, Head of Safety Information Management and Automation, Johnson & Johnson, United States
Beth is a pharmaceutical executive with deep expertise in Pharmacovigilance (PV) at Johnson & Johnson (J&J). Beth has over 30 years of global pharmaceutical leadership experience developing and executing strategies, driving operational excellence, and ensuring compliance with worldwide... Read More →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

2:30pm EDT

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives
Monday June 15, 2026 2:30pm - 3:30pm EDT
108B
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-527-L04-P; CME 1.00; RN 1.00No one can solve today’s R&D challenges alone. But are industry consortia fit for 2030? We examine the "head, heart, and gut" to re-imagine collaboration and explore what’s needed to accelerate co-creation and innovation.Learning Objectives Recognize the value of industry...
See More →
Speakers
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
JS

Jeff Smith

The Curator, Smith and Jones Innovation, United States
avatar for Sarah Tremethick

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom
A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

2:30pm EDT

#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Monday June 15, 2026 2:30pm - 3:30pm EDT
108A
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-528-L04-P; CME 1.00; RN 1.00Explore patient-focused decentralized trials and direct-to-patient shipments, highlighting their impact on recruitment, retention, and trial performance—and how sites adapt operations to deliver these solutions effectively.Learning Objectives Evaluate how DCT solutions and...
See More →
Speakers
avatar for Joan Chambers

Joan Chambers

Independent Senior Consultant, Tufts Center For the Study of Drug Development, United States
With 30+ years in the health and life sciences industry, Joan has led senior initiatives across multiple organizations, specializing in team leadership, strategic planning, integrated marketing, communications, and educational programs for B2B and B2C audiences. She is a Senior Independent... Read More →
avatar for Kevin Hudziak

Kevin Hudziak

Senior Director - Patient Engagement, Clinical Trial Retention, Eli Lilly and Company, United States
Kevin is Senior Director of Clinical Trial Retention on the Patient Engagement team at Lilly. He has extensive experience gathering patient and site feedback, delivering innovation, and impacting DCT capability development and implementation at Lilly. Kevin has a passion for improving... Read More →
avatar for Becky Kottschade

Becky Kottschade

Administrator, Clinical Research, Mayo Clinic, United States
Becky Kottschade is an experienced clinical research administrator. Driven by her commitment to developing innovative options for patients she takes pride in providing the best practices for implementing decentralized capabilities possible. As a research administrator her goals are... Read More →
avatar for Jane Myles

Jane Myles

VP, Programs and Initiatives, Digital Trials and Research Alliance, United States
Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   09: RD-Quality-Compliance, Forum

2:30pm EDT

#433: ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science
Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-529-L04-P; CME 1.00; RN 1.00Explore how ICH M11, AI, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design, streamline submissions, and foster patient-centered innovation.Learning Objectives Describe how...
See More →
Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
avatar for Jimita Parekh

Jimita Parekh

Managing Director, Independent, United States
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
MS

Mumtaz Sultani

European Medicines Agency, Netherlands
Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

2:30pm EDT

#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead)
Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-530-L04-P; CME 1.00; RN 1.00This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.Learning Objectives Explain how current CDISC...
See More →
Speakers
avatar for James Browning

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 16 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
avatar for Chris Decker

Chris Decker

President and CEO, CDISC, United States
Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →
AM

Anne-Marie Meyer

Advisor, Lind AI, Switzerland
Dr. Meyer is Vice President of Healthcare Consulting at acc solutions and advisor to LindAI. As Adjunct Associate Professor at UNC Chapel Hill, she has bridged epidemiology and health informatics for 20+ years. At Lineberger Cancer Center, she built a secure data platform linking... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Data Management & Data Standards,Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum

2:30pm EDT

#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise
Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-531-L04-P; CME 1.00; RN 1.00This session will describe essential AI-related skills for medical writers to leverage AI responsibly for greater efficiency while ensuring compliance and scientific integrity. The speakers will discuss how medical writers are becoming AI stewards.Learning Objectives Define the...
See More →
Speakers
avatar for Eileen Girten

Eileen Girten

Medical Writing Therapeutic Area Lead, Pfizer, United States
Eileen M. Girten serves as the Medical Writing Therapeutic Area Lead at Pfizer and brings nearly 17 years of medical writing experience spanning publications and regulatory documentation. She holds a Bachelor of Arts in Chemistry from Rosemont College, a Master of Science in Psychology... Read More →
avatar for Mary Ost

Mary Ost

Director, AI-assisted Operations, Regulatory Medical Writing, Johnson & Johnson , United States
Mary Ost, PhD, is Director of AI-assisted Operations for Regulatory Medical Writing at Johnson & Johnson Innovative Medicine, with 30 years of experience across the pharma and CRO spaces. As AI-assisted Operations Lead, Mary has defined strategy and led solution deployment for AI-driven... Read More →
avatar for Jeanette Towles

Jeanette Towles

CEO, Synterex, United States
Jeanette Towles, MA, RAC is the Founder and CEO of Synterex, Inc., a clinical and regulatory consulting firm pioneering the digital transformation of regulatory science in life sciences and healthcare. Under her leadership, Synterex is developing a digital regulatory ecosystem—a... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session

2:30pm EDT

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development
Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P; CME 1.00; PDU 1.00 PMI 21665YGZQV ; RN 1.00This seminar shows how life sciences teams can align strategy with execution through integrated program plans, AI-enabled planning, and P3M practices to accelerate time to market, foster innovation, and drive organizational transformation.Learning Objectives...
See More →
Speakers
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Christine Mears

Christine Mears

Founder, Lead Consultant, Premiere Consulting Services LLC, United States
Christine M. Mears is an enterprise program, portfolio, and operations executive with 25+ years of experience driving strategy execution and operational performance. Formerly at Eli Lilly in a COO-level capacity, she led global programs, launches, and transformations. As Founder of... Read More →
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Analysis & Management, Daiichi Sankyo Co., Ltd., United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
avatar for Philip Zack

Philip Zack

Executive Life Sciences Consultant Portfolio, Program and Alliance Management, Self-Employed, United States
Phil Zack has 25 years experience in the biopharmaceutical industry and research. He has held Portfolio, Program and Alliance Management leadership positions within NeXstar, Gilead, Amgen, Vertex, and Myovant Sciences. He has experience in all phases of drug development, in multiple... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session |   07: RegCMC-Product Quality, Session |   02: ClinicalTrialOps-Innovation, Session

2:30pm EDT

#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C
Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Application UAN: 0286-0000-26-533-L04-P; CME 1.00; RN 1.00Artificial intelligence is revolutionizing drug manufacturing, yet regulations are still catching up. With key guidance from the EU and US in development, a proactive and collaborative approach is needed for global regulatory alignment, ensuring AI iLearning Objectives Identify and...
See More →
Speakers
avatar for Tina Kiang

Tina Kiang

Director, Division of Regulation and Guidance, OPPQ, OPQ, CDER, FDA, United States
Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation and Guidance in OPQ/OPPQ. She has over 20 years of combined regulatory and leadership experience at the FDA. Tina has led and supervised the development and finalization of guidance and regulations on... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
TO

Thomas O'Connor

Director Process Analytics, GSK, United States
Tom is a director for process analytics at GSK. His team develops models to accelerate process development and increase the robustness of commercial manufacturing. Tom joined GSK from the FDA where he was the deputy director of the Office of Pharmaceutical Quality Research in the... Read More →
avatar for Gert Thurau

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   03: Data-Tech-AI, Session
  • Audience Advanced
  • Area Artificial Intelligence
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session

2:30pm EDT

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA
Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB
Component Type: SessionLevel: AdvancedChina is reshaping global drug development and regulatory strategy. This session equips MNC regulatory leaders with decision framework, actionable strategies, pathway insights, and case studies to optimize China integration and global approvals.Learning Objectives Assess China’s evolving regulatory landscape to inform global portfolio strategy; Examine...
See More →
Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
avatar for Wenny Du

Wenny Du

Sr. Director, Global Regulatory Lead, Amgen Inc., United States
Wenny Du, MS, MBA, RAC, serves as Senior Director and Global Regulatory Lead (GRL) for Oncology at Amgen Inc., where she leads global regulatory teams to shape and execute strategies that enable worldwide innovative medicine approvals. With over 25 years of biopharmaceutical industry... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
avatar for Wei Zhang

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China
Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

2:30pm EDT

#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB
Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P; CME 1.00; RN 1.00Global interest in early intervention for chronic diseases is driving regulatory innovation, but evidence and reimbursement barriers remain. This forum will highlight how global agencies and payers are adopting harmonized, patient-focused approaches.Learning Objectives Analyze global...
See More →
Speakers
avatar for Julian Beach

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →
avatar for Simon Bennett

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →
MC

Mindy Cameron

Patient Advocate, Advocacyworks, United States
Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

2:30pm EDT

#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-534-L04-P; CME 1.00; RN 1.00Sponsors are increasingly leveraging regulatory collaboration and reliance approaches. In this Forum, international regulatory and industry experts will review ongoing pilot projects and discuss future opportunities. Learning Objectives Discuss Industry experience with reliance...
See More →
Speakers
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s... Read More →
JP

Joann Parker

Vice President of Regulatory CMC, Pfizer, United States
avatar for Amanda Roache

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

2:30pm EDT

#442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, MHRA, and PMDA
Monday June 15, 2026 2:30pm - 3:30pm EDT
204AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-535-L04-P; CME 1.00; RN 1.00Senior leaders from FDA, EMA, MHRA and PMDA share insights on AI’s evolving role in regulatory review & decision-making. Attendees will explore current practices, key challenges, and future opportunities for AI in shaping global regulatory frameworks.Learning Objectives Discuss how AI is...
See More →
Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States
Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →
TN

Tomoharu Numanyu

Senior Reviewer, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Tomoharu Numanyu is a Senior Scientific Officer in the Office of New Drug Review I at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. After obtaining his pharmacist license, he worked in the pharmaceutical industry for three years before joining PMDA in 2016. From 2016... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   03: Data-Tech-AI, Forum
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Regulatory
  • Feature Topics Artificial Intelligence
  • Tags Forum

2:30pm EDT

#438: A Conversation About Quality: A Global Regulators Discussion
Monday June 15, 2026 2:30pm - 3:30pm EDT
201AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-537-L04-P; CME 1.00; RN 1.00This forum will present the perspectives of global regulatory agencies on encouraging a high standard for quality in pharmaceutical products. The panel will discuss their vision, key initiatives, challenges on how to improve drug quality worldwide.Learning Objectives Describe regulatory...
See More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   09: RD-Quality-Compliance, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Forum

2:30pm EDT

#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Monday June 15, 2026 2:30pm - 3:30pm EDT
117
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-538-L04-P; CME 1.00; RN 1.00This forum will present Health Authority (HA) expectations related to a robust Culture of Quality focused on Critical-to-Quality (CtQ) issue management. This session will provide specific examples of how leadership commitment and employee ownership enable a robust Quality Culture.Learning...
See More →
Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
SI

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Forum

2:30pm EDT

#444: Driving Efficiency in Clinical Development with Master Protocols
Monday June 15, 2026 2:30pm - 3:30pm EDT
116
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-539-L04-P; CME 1.00; RN 1.00Master protocols are innovative designs for simultaneous evaluation of multiple drug or population under one protocol, enhancing efficiency. Despite their potential, these protocols pose complex scientific, operational, and regulatory challenges.Learning Objectives Explain the...
See More →
Speakers
HC

Haitao Chu

Senior Director, Pfizer, United States
Dr. Haitao Chu is a Senior Director at Pfizer’s Statistical Research and Data Science Center, a role he has held since 2022. He earned his PhD in Biostatistics from Emory University. Dr. Chu has held several academic appointments, including Assistant Professor of Epidemiology at... Read More →
avatar for Megan McCabe

Megan McCabe

Assistant Professor, Department of Biostatistics, The University of Alabama at Birmingham, United States
Megan McCabe is an Assistant Professor in the Department of Biostatistics at the University of Alabama at Birmingham (UAB), and the Assistant Director for Clinical Trials Development for the UAB DATA coordinating and Collaborative Research Unit (DATA CRU). She graduated with her PhD... Read More →
PP

Purvi Prajapati

Sr. Advisor, Eli Lilly, United States
Purvi earned her PhD in Statistics from Baylor University prior to joining Lilly in 2020. Since joining she’s been a member of the Clinical Design Team where she collaborates with multiple study teams to design clinical trials across all phases of drug development across the immunology... Read More →
avatar for Satrajit Roychoudhury

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States
Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs, Digitalization, Global Learning
Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P; CME 1.00; RN 1.00This session shares US, EU and global expertise and experiences on methods to tailor risk minimization interventions and digital implementation support to special patient populations (e.g. female, young and older patients) in local contexts.Learning Objectives Describe needs and methods...
See More →
Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →
avatar for Delese Mimi Darko

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →
avatar for Jean-Christophe Delumeau

Jean-Christophe Delumeau

Senior Expert, Institute of Pharmacovigilance, Czech Republic
Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Partner & PV trainer, Eliquent Life Sciences, United Kingdom
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Meredith Yearsley Smith

Meredith Yearsley Smith

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session

4:00pm EDT

#446: DIA2026-001: Co-Creating the Patient-Centric Trial Live
Monday June 15, 2026 4:00pm - 5:00pm EDT
108A
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-541-L04-P; CME 1.00; RN 1.00In this interactive forum, attendees will co-create “DIA2026-001” through live polling, exploring how early protocol decisions shapes: patient inclusion, recruitment feasibility, technology strategy, operational complexity. With perspectives from patient advocacy, recruitment and...
See More →
Speakers
AC

Alexandra Charge

CEO, ISPEP, United Kingdom
A global life sciences executive, specialising in strategic transformation, innovation, and patient-centric approaches in healthcare, medicines development and clinical trial optimisation. As the CEO of the International Society for Patient Engagement Professionals, Alex is an active... Read More →
avatar for Farrell Healion

Farrell Healion

Founder & Managing Director, Optitrial, United Kingdom
Farrell Healion is the Founder and Principal Consultant of OptiTrial, where he partners with sponsors and study teams to deliver smarter, faster, and more connected clinical trials. With over 13 years of experience across sponsor and clinical technology roles, including at AstraZeneca... Read More →
RJ

Ross Jackson

Patient Recruitment Specialist, Ross Jackson Consulting, United Kingdom
A patient recruitment consultant who's worked on nearly 200 successful projects. Author of two Amazon best-selling books on patient recruitment, Ross provides advice and oversight to organizations that wish to improve the effectiveness of their patient recruitment activities - sponsors... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum

4:00pm EDT

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P; CME 1.00; RN 1.00This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory collaboration, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.Learning Objectives Analyze how regulatory...
See More →
Speakers
avatar for Yoko Aoi

Yoko Aoi

Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a Coordination Director, Office of Review Management at the PMDA of Japan. After joining PMDA, Dr. Aoi has been involved in regulatory review/scientific advice for new drugs, including treatments for rheumatoid arthritis, asthma, and COPD (2011–2016); coordination... Read More →
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
Dr. Aloka Chakravarty is VP, Statistical Data Insights and Advanced Analytics at Eli Lilly. Prior to that, she was the Director, Office of Biostatistics(A) at FDA where her career spanned 31 years. She is recipient of FDA Award of Merit, the highest scientific award conferred by the... Read More →
avatar for Angelika Joos

Angelika Joos

Executive Director, Science & Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Clinical Research Policy issues within MSD's Science & Regulatory Policy department. This role includes identifying policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →
PV

Paz Vellanki

Associate Director, OND, CDER, FDA, United States
avatar for Sarah White

Sarah White

Executive Director, MRCT Center, United States
Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Area Global Alignment in Practice
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations,Regulatory
  • Feature Topics Global Alignment in Practice
  • Tags Forum

4:00pm EDT

#449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications
Monday June 15, 2026 4:00pm - 5:00pm EDT
111AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-543-L04-P; CME 1.00; RN 1.00This session shares insights from a global survey of 12,000+ respondents, highlighting patient comfort levels and receptivity to AI processing their medical information as part of a clinical trial. Learning Objectives Discuss patient comfort levels and receptivity to AI processing...
See More →
Speakers
avatar for Annick De Bruin

Annick De Bruin

Chief Research and Insights Officer, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP), United States
Annick de Bruin is the Chief Research and Insights Officer of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including... Read More →
SG

Shanelle Gabriel

Patient Advocate, N/A, United States
SG

Shanelle Gabriel

Patient Advocate/Speaker/Poet, Building Constellations, LLC, United States
Shanelle Gabriel is an internationally touring poet, speaker, communications consultant, and lupus patient advocate. She has performed globally gracing stages from Carnegie Hall to the Vatican. As a creative strategist, she has crafted poetry on various themes for events and for campaigns... Read More →
avatar for Ellyn Getz

Ellyn Getz

Director, R&D Patient Engagement, CSL Behring, United States
Ellyn Getz, MPH is the Director of R&D Patient Partnerships at global biotech CSL, where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States
T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   02: ClinicalTrialOps-Innovation, Session

4:00pm EDT

#448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness
Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-544-L04-P; CME 1.00; RN 1.00Discover Coalition For Epidemic Preparedness Innovations (CEPI) Pandemic Preparedness Engine (PPE) regulatory node—a forward-looking digital platform using AI and cloud technology to accelerate vaccine approvals through structured data, automated workflows, and global collaborative...
See More →
Speakers
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory policy and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
MC

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
MC

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
avatar for Ashley Jones-Mitchell

Ashley Jones-Mitchell

Head of Global Regulatory Policy, Accumulus Synergy, United States
Ashley is Head of Global Regulatory Policy for Accumulus Synergy. With over 19 years of experience in the federal government and industry, Ashley advocates for policies that will advance digital transformation. Prior to her time at Accumulus Synergy, Ashley was with the U.S. Food... Read More →
TS

Teginder Singh

Global Head Regulatory Quality Safety, Google, United States
Teginder Singh is a senior executive and pharmacist with over 25 years of leadership in health & life sciences. His early career focused on drug discovery, and he has since led complex transformation programs across R&D, Regulatory, Quality and Safety at Fortune50 companies like Google... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

4:00pm EDT

#450: Medical Writing Ted Experience
Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-545-L04-P; CME 1.00; RN 1.00Medical writing myths persist, including the assumption that “anyone can write” and “an AI can write this in 10 minutes”—even as the stakes for clarity, accuracy, and scientific integrity continue to rise. In this TED-talk–style session, three presenters will explore why...
See More →
Speakers
avatar for Monica Chiaramonte

Monica Chiaramonte

Director, Clinical Regulatory Writing, AstraZeneca, United States
Monica Chiaramonte is a Director of Clinical Regulatory Writing at AstraZeneca, with over 35 years in the scientific field and 19 years in Medical Writing across CRO and pharmaceutical settings. She brings deep expertise in authoring and leading high quality regulatory submissions... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
AW

Anna Whitling

Senior Manager of Medical Writing, Alcon Laboratories, Inc, United States
Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   03: Data-Tech-AI, Forum

4:00pm EDT

#451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes
Monday June 15, 2026 4:00pm - 5:00pm EDT
116
Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P; CME 1.00; RN 1.00Real-world data that encompass race, ethnicity, or ancestry and clinical phenotypes are growing increasingly sophisticated in utility. This panel will discuss why precision medicine is ripe for new and ongoing exploration in regulatory contexts.Learning Objectives Describe precision medicine...
See More →
Speakers
avatar for Lysel Brignoli

Lysel Brignoli

Associate Principal, RWE, Oracle Life Sciences, France
Lysel Brignoli is an expert in Real-World Evidence and epidemiologic research, with over a decade of experience designing and leading studies that generate insights for healthcare decision-making. Her work focuses on innovative study designs, patient registries, and the integration... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States
Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Session

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB
Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00Mentorship Myth Busters uses a courtroom-style format where attendees vote on mentorship myths and learn from experts. The REAL framework guides participants toward inclusive, flexible, and sustainable mentoring practices.Learning Objectives Assess mentorship myths...
See More →
Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive Director, Human Resources, United States
Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
avatar for Sabhorak Horn

Sabhorak Horn

Medical Omnichannel Education Manager, Eli Lilly and Company, United States
Sabhorak Horn is a licensed pharmacist with a dual degree from the Philadelphia College of Pharmacy. Sabo is driven by his long-term vision of leading innovation in pharma. He is passionate about medical affairs as the bridge between data, people, and real-world impact, with a growing... Read More →
avatar for Carol Morales

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management & Capabilities Lead with a strong focus on professional development, mentorship, and building sustainable learning cultures within the life sciences. She brings extensive experience in designing and leading development initiatives that bridge... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session

4:00pm EDT

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P; CME 1.00; RN 1.00Explore regulatory and manufacturing challenges in cell and gene therapy, including starting material variability, potency testing, comparability, specification, and stability strategies. Gain insights into FDA expectations, ICH initiatives, and collaborative approaches to harmonize...
See More →
Speakers
avatar for Kevin Carrick

Kevin Carrick

Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States
Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment... Read More →
avatar for Andrew Chang

Andrew Chang

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a member of the board of directors for Parenteral Drug Association (PDA). Andrew has served as a member of the planning committee for DIA... Read More →
avatar for Akanksha Kaushal

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States
Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session

4:00pm EDT

#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-549-L04-P; CME 1.00; RN 1.00The Middle East is a fast-emerging innovation hub. Aligning with global standards, the region is opening new opportunities and incentives. Join us to discover Middle Eastern innovations and why companies should view it as a top investment destination.Learning Objectives Discuss how the...
See More →
Speakers
avatar for Amira Younes

Amira Younes

Director- Europe, Middle East & Africa (EMEA), Global Regulatory Policy, MSD, United Arab Emirates
Amira is Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years’ experience in regulatory science and policy. A recognized thought leader in regulatory reliance, work sharing, and harmonization, she builds cross-sector networks to strengthen... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

4:00pm EDT

#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P; CME 1.00; RN 1.00This session will explore innovative regulatory approaches, including the ICH E11A guideline, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis. Learning Objectives Identify innovative regulatory strategies for pediatric...
See More →
Speakers
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →
LJ

Laura Jawidzik

Division Director, Division of Neurology 2 (DN2), OND, CDER, FDA, United States
Dr. Jawidzik is a board-certified neurologist and the director of the Division of Neurology 2 (DN2) at FDA. She joined the Agency in 2015 in DN2 as a clinical reviewer on the migraine/TBI/stroke team. In 2020, she moved from DN2 to DN1 and has served in various positions in DN1 including... Read More →
LK

Lauren Krupp

Director, Multiple Sclerosis Comprehensive Care Center, NYU Langone Health, United States
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum

4:00pm EDT

#455: Japan Town Hall
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P; CME 1.00; RN 1.00This session explores the benefits of drug development and approval in Japan, highlighting market size, development predictability, and regulatory support, with insights from administrative bodies and the international pharmaceutical industry.Learning Objectives Recognize misconceptions...
See More →
Speakers
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
SU

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

4:00pm EDT

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB
Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00Explore the science and debate surrounding the FDA’s use of surrogate endpoints in drug approvals, with a focus on their role in addressing unmet medical needs. This session will bring together diverse perspectives to clarify misconceptions. Learning Objectives Describe an evidence-based...
See More →
Speakers
JA

Jenny Ahlstrom

Founder & CEO/Multiple Myeloma Patient, HealthTree, United States
KB

Kara Berasi

CEO, Haystack Project, United States
Kara Berasi started working in patient advocacy after her son was diagnosed with a rare disease. She has a personal passion to change the landscape of care as it relates to those living with rare diseases. She is the CEO of Haystack Project, an umbrella organization representing over... Read More →
avatar for Bridget Doherty

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson, United States
Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Area Evidence Innovation
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum

4:00pm EDT

#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations
Monday June 15, 2026 4:00pm - 5:00pm EDT
117
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-552-L04-P; CME 1.00; RN 1.00Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends, highlighting compliance patterns, regulatory harmonization, and industry strategies for sustaining quality in complex global trialsLearning Objectives Examine GCP inspection classification and...
See More →
Speakers
avatar for Rachel Mead

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Rachel joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a GCP Inspector in July 2019. She conducts a wide range of routine and triggered GCP inspections across both commercial and non commercial organisations, including Phase 1 units registered under the MHRA... Read More →
avatar for Jenn Sellers

Jenn Sellers

Chief, GCP Assessment Branch, FDA, United States
Dr. Sellers serves as Chief of the Good Clinical Practice (GCP) Assessment Branch in the Office of Scientific Investigations at the U.S. FDA, where she leads the evaluation of GCP compliance and provides regulatory recommendations in support of marketing applications. She is a board-certified... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   02: ClinicalTrialOps-Innovation, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

4:00pm EDT

#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding
Monday June 15, 2026 4:00pm - 5:00pm EDT
107AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-554-L04-P; CME 1.00; RN 1.00This session highlights methodological challenges in External Control Arms (ECAs) using Real-World Data (RWD). Speakers will address time-related biases, endpoint alignment challenges between RWD and trial standards, and methodological strategies to address unmeasured...
See More →
Speakers
avatar for Benjamin Ackerman

Benjamin Ackerman

Principal Scientist, Biostatistics, Johnson & Johnson, United States
Ben Ackerman is a Principal Scientist at Johnson & Johnson Innovative Medicine, where he provides support across therapeutic areas to design and analyze randomized trials, namely those that combine trial data with real-world data. He has expertise in causal inference methods to address... Read More →
avatar for Benjamin Ackerman

Benjamin Ackerman

Director, Real-world Biostatistics, GSK, United States
Ben Ackerman is a Director of Real-world Biostatistics at GSK, where he designs and analyzes real-world evidence studies in oncology. He has expertise in causal inference methods to address various biases in both randomized trials and non-experimental studies. Previously, he led a... Read More →
JH

Ju Hwan Kim

Research Professor, Sungkyunkwan University, Korea, Republic of
Ju Hwan (Joe) Kim, PharmD, PhD, is a Research Professor at the School of Pharmacy, Sungkyunkwan University, South Korea. His work spans pharmacoepidemiology, clinical pharmacy, regulatory science, and real-world data/evidence. He leads international collaborative studies leveraging... Read More →
avatar for Gerd Rippin

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?
Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P; CME 1.00; RN 1.00This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regionsLearning Objectives Explain the current guidance and...
See More →
Speakers
avatar for Gracy Crane

Gracy Crane

Policy Lead, Roche, United Kingdom
Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →
TL

Tricia Luhn

RWD Oncology, Genentech, United States
TL

Tricia Luhn

RWD Oncology, Genentech, A Member of the Roche Group, United States
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Evidence Innovation
  • Tags Forum
 
Tuesday, June 16
 

8:00am EDT

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies
Tuesday June 16, 2026 8:00am - 9:00am EDT
114
Component Type: SessionLevel: IntermediateThis plenary session will bring together first-hand perspectives from academic and pharmaceutical experts involved in the development of the GLP1 therapies that first achieved regulatory approval for the treatment of obesity. Speakers will reflect on the scientific and clinical journey that enabled these breakthroughs, while examining how innovation in...
See More →
Speakers
avatar for W. Scott Butsch

W. Scott Butsch

International Medical Vice President - Obesity, Novo Nordisk A/S, Denmark
avatar for Robert Califf

Robert Califf

Instructor, Medicine, Duke University School of Medicine, United States
Dr. Robert Califf is an Adjunct Professor of Medicine at Duke University and a practicing cardiologist. He served as FDA Commissioner (2016–2017) and Deputy Commissioner for Medical Products and Tobacco. At Duke, he was Vice Chancellor for Clinical and Translational Research and... Read More →
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Tuesday June 16, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  00: Plenary, Session |   02: ClinicalTrialOps-Innovation, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

9:15am EDT

#501 IT: Weave Bio Innovation Theater: Threading AI Throughout the Drug Development Lifecycle - An Enterprise Lens
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 3
Component Type: SessionPressures to go faster and do more with less continually rise, and enterprise pharma organizations experience these pressures at scale. Quality cannot be compromised when rapidly constructing sophisticated, layered health authority narratives with evolving data. Questions from health authorities must be responded to with speed and precision. New technology offers relief, but...
See More →
Speakers
avatar for Andrew Robertson

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

9:15am EDT

#502 IT: IQVIA Innovation Theater: From Insight to Impact - Leveraging Patient Experience Data Through Technology and AI
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 1
Component Type: SessionThis session examines persistent scientific and operational challenges in eCOA implementation, particularly in studies using high frequency patient reported data. The discussion focuses on how advanced monitoring technologies and AI driven analytics can be used to detect emerging risks such as disengagement, response drift, and early signal degradation while data collection...
See More →
Speakers
avatar for Lindsay Hughes

Lindsay Hughes

Principal, RDS, IQVIA, United States
Lindsay Hughes, PhD is a Principal in IQVIA’s Patient Centered Solutions practice, with nearly two decades of experience in behavioral and life sciences. Her work focuses on understanding how people interact with technology in clinical research settings and applying that insight... Read More →
avatar for IQVIA

IQVIA

United States
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

9:15am EDT

#503 IT: Parexel Innovation Theater: Human-Centered AI - A Dual-Layer Model for Clinical Research Excellence
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 2
Component Type: SessionLearn about early wins from enterprise AI solutions: How these solutions have delivered measurable gains in speed, automation efficiency, and data quality without displacing human expertise. Explore Parexel use cases: the emergence of a second innovation layer driven by citizen developers (CRAs), who built targeted AI tools that automate labor intensive workflows and enhance...
See More →
Speakers
avatar for Boris Braylyan

Boris Braylyan

Chief Digital & Data Officer, Parexel, United States
Boris Braylyan is a technology leader with over two decades of experience advancing digital innovation in regulated industries. His career spans large scale transformations in life sciences, including 20 years at Pfizer, where he modernized global clinical and regulatory systems and... Read More →
avatar for Parexel

Parexel

United States
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration
Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-555-L04-P; CME 1.25; RN 1.25This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups, to FDA pilots applying AI at scale, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.Learning Objectives Identify algorithmic...
See More →
Speakers
avatar for Raymond Kassekert

Raymond Kassekert

Executive Director, PV Systems Management, GSK, United States
Ray is Executive Director and Head, PV Systems at GlaxoSmithKline. In this role, Ray is responsible for the global technology platforms supporting Pharmacovigilance and Drug Safety. In addition, Ray is a member of the ICH E2B(R3) Implementation Working Group and a member of the MedDRA... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Daniele Sartori

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden
Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session |   03: Data-Tech-AI, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Clinical Safety & Pharmacovigilance
  • Feature Topics Artificial Intelligence
  • Tags Session

10:15am EDT

#506: From Barriers to Bridges: Unlocking Research Potential in Primary Care
Tuesday June 16, 2026 10:15am - 11:30am EDT
108B
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-556-L04-P; CME 1.25; RN 1.25Too few sponsors and sites have access to primary care organizations (PCOs). PCOs deliver first-contact, comprehensive, and continuous care to over 100 million people. This session will bring forth easy to use and action oriented PCO tactics.Learning Objectives Distinguish between types...
See More →
Speakers
avatar for Ruma Bhagat

Ruma Bhagat

Process Excellence Leader, Genentech, A Member of the Roche Group, United States
OE

Osa Eisele

Executive Director, Amgen, United States
Osa Eisele, MD, MPH, is a physician-scientist and global health leader with over 20 years of experience in drug safety, clinical research, and population health. As Head of Representation in Clinical Research (RISE) at Amgen, she advances proportional representation in clinical trials... Read More →
avatar for Pete Fronte

Pete Fronte

Founder and Chief Executive Officer, Altura, United States
Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within primary care organizations and community... Read More →
MM

Maggie McGuire Kuhl

Vice President, Patient Engagement, The Michael J. Fox Foundation For Parkinson's Research, United States
RP

Rakesh Patel

CEO, Neighborhood Healthcare (FQHC), United States
Dr. Rakesh Patel is the Chief Executive Officer (CEO) for Neighborhood Healthcare, Neighborhood Healthcare PACE, and Neighborhood Healthcare Institute of Health. Neighborhood Healthcare is a 501(c)3 nonprofit Federally Qualified Health Center (FQHC) with 30 Health Centers serving... Read More →
AP

Alpa Patel

Senior Vice President, Population Science, American Cancer Society, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

10:15am EDT

#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation
Tuesday June 16, 2026 10:15am - 11:30am EDT
107AB
Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Application UAN: 0286-0000-26-557-L04-P; CME 1.25; RN 1.25We will share case examples and trends from 24,000 records, analyze ethical challenges involved in paying participants, and discuss how protective policies or administrative practices can result in unjust treatment.Learning Objectives Explain the ethical considerations that govern payment...
See More →
Speakers
avatar for Karla Childers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States
Karla Childers is Vice President, Bioethics, Policy & Partnerships in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →
avatar for Kelly FitzGerald

Kelly FitzGerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States
Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →
avatar for Wenora Johnson

Wenora Johnson

Administrative Support & Research/Patient Advocate, United States
avatar for Robin Kuprewicz

Robin Kuprewicz

Clinical Trials Director, Georgetown University, United States
Robin Kuprewicz is the Clinical Trials Director for the Georgetown University Huntington's Disease Care, Education and Research Center. She holds a Masters in Medical Anthropology and has ten years of experience in clinical trials. She has helped Huntington's Disease participants... Read More →
SW

Sam Whitaker

Founder & CEO, Mural Health, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

10:15am EDT

#505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing
Tuesday June 16, 2026 10:15am - 11:30am EDT
108A
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-558-L04-P; CME 1.25; RN 1.25Learn how mixed FSP (functional service provider)/FSO (full-service outsourcing) models deliver additional agility to help clinical trial sponsors manage complexity, enhance efficiency, and facilitate the transition from FSO to FSP outsourcing. Learning Objectives Identify opportunities...
See More →
Speakers
avatar for Samantha Hadfield

Samantha Hadfield

Vice President, Operational Delivery, PPD FSP solutions, Thermo Fisher Scientific, United Kingdom
avatar for Nick Scott

Nick Scott

Head, Strategic Resourcing and Performance Optimization, Biogen, United States
avatar for Andrew Studna

Andrew Studna

Senior Editor, Applied Clinical Trials, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   01: ClinSafety-PV-RM, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Tags Forum

10:15am EDT

#515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development
Tuesday June 16, 2026 10:15am - 11:30am EDT
112AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-566-L04-P; CME 1.25; RN 1.25This session covers the importance of data sharing and the new tools that might enable that pooling and integration in order to facilitate progress in personalized medicine and ensure faster access to treatments for the oncology patients who need them the most.Learning Objectives Discuss...
See More →
Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Editor-in-Chief, DIA Global Forum, United States
Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion... Read More →
avatar for Joseph Kannarkat

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States
Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →
avatar for Sean Khozin

Sean Khozin

CEO, Roundtable on Cancer (CEORT) and Project Data Sphere (PDS), United States
Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine... Read More →
avatar for Beth Meagher

Beth Meagher

Principal, Deloitte Consulting, United States
Beth Meagher is a Deloitte Consulting LLP principal and leader of the Federal Monitor Deloitte Strategy practice. She started and leads Deloitte's Translational Medicine, which bring strategy, informatics, clinical, and research capabilities together on collaborative teams. Beth focuses... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session

10:15am EDT

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech
Tuesday June 16, 2026 10:15am - 11:30am EDT
103A
Component Type: SessionLevel: IntermediateMany clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.Learning Objectives Design and execute a streamlined customer discovery process to validate unmet needs, buying...
See More →
Speakers
LH

Laura Hilty

Principal, HealthX Ventures, United States
JL

Jeff Lee

Board Director, Medstar Health Research Institute, United States
Jeff Lee is a seasoned entrepreneur, angel investor, and venture partner with a strong background in business development and entrepreneurship. He successfully founded/exited mProve Health and held leadership roles in several other startups with successful exits. Jeff also serves... Read More →
PS

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States
Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →
DS

Dan Sndyer

The Playbook, United States
DS

Dan Sndyer

The Playbook, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session |   18: Lift-Series, Session

10:15am EDT

#513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA
Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-565-L04-P; CME 1.25; RN 1.25Chronic Disease Town Hall spotlights emerging programs and global initiatives for chronic disease drug development, outlines the current landscape, explores opportunities and challenges, and assesses strategies to boost efficiency and accelerate therapeutic innovation. Learning...
See More →
Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Ayaka Kubota

Ayaka Kubota

Office of Safty II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
She is a reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is involved in the scientific review of pharmaceuticals, primarily focusing on cardiovascular drugs and treatments for Alzheimer’s disease, with an emphasis on clinical evaluation and regulatory... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States
Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

10:15am EDT

#508: How Standardized Protocol Data Plus AI Power Patient Centric Studies
Tuesday June 16, 2026 10:15am - 11:30am EDT
111AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-560-L04-P; CME 1.25; RN 1.25Clinical trial start-up is often delayed by manual processes, fragmented systems, and inconsistent data. This workshop will explore how biopharmaceutical companies are using AI and interoperable data standards to enable patient centric study designs.Learning Objectives Explain how AI...
See More →
Speakers
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), The Synergist, Belgium
Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
avatar for Vivian Dewoskin

Vivian Dewoskin

Chief Commercial Officer, Faro Health Inc., United States
Vivian is the Chief Commercial Officer at Faro, where she leads sales, marketing, and commercial strategy. She works closely with Faro’s customers to understand their needs and goals, and translate them into Faro’s product development roadmap. Prior to Faro, Vivian held multiple... Read More →
avatar for William Illis

William Illis

Executive Director, Technology and Scientific Computing, Novartis , United States
Bill is Executive Director, Technology and Scientific Computing in the Advanced Quantitative Sciences line function at Novartis. He responsible for developing and implementing the analytics technology strategy focused on end-to-end clinical data flows, systems and processes. For the... Read More →
avatar for Sahishnu Patel

Sahishnu Patel

Associate Director, AI and Automation R&D, Synterex, United States
Sahishnu Patel, PhD, is Associate Director of AI and Automation R&D at Synterex, where he leads the design, validation, and responsible deployment of AI-enabled medical and regulatory solutions. His work focuses on building high-impact generative and agentic systems, advancing scalable... Read More →
avatar for Prasanna Rao

Prasanna Rao

Chief Products and Innovation Officer, Saama, United States
Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Senior Director, Global Head of AI/ML, Clinical Data Sciences, Pfizer R&D. With over 30 years of experience in information technology and analytics, including more than a decade in... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Workshop

10:15am EDT

#509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development
Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-559-L04-P; CME 1.25; RN 1.25This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency level initiatives.Learning Objectives Describe FDA's current...
See More →
Speakers
avatar for Marie Bradley

Marie Bradley

Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee... Read More →
avatar for Hussein Ezzeldin

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States
Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

10:15am EDT

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate
Tuesday June 16, 2026 10:15am - 11:30am EDT
203AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-561-L04-P; CME 1.25; RN 1.25Explore how FDA’s Clinical Decision Support (CDS) guidance impacts software classification in drug development. Learn to apply a decision tree through real-world case studies and a hands-on workshop to determine whether a tool is a regulated medical device or exempt CDS.Learning...
See More →
Speakers
avatar for Lesley Maloney

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →
avatar for Jeppe G. Manuel

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark
Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation... Read More →
MM

Michael Mayrosh

Associate Director Global Regulatory Policy and Strategy, Eli Lilly and Company, United States
Mike Mayrosh is an Associate Director, Global Regulatory Policy and Strategy for Eli Lilly and Company. Mike leads Lilly's policy work on E-labeling, Artificial Intelligence, Digital Health Technologies, and Clinical Trial Modernization. Mike earned his PharmD from the University... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Workshop |   02: ClinicalTrialOps-Innovation, Workshop |   08: RegPolicy-Strategy-GlobalCollaboration, Workshop

10:15am EDT

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management
Tuesday June 16, 2026 10:15am - 11:30am EDT
202AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-562-L04-P; CME 1.25; RN 1.25This workshop will focus on the principles of enhanced analytical procedure development, and use of prior knowledge in creating robust methods. It will include industry case studies, a regulator’s perspective, and a debate-style panel. Part 2 of this workshop is Future of Enhanced...
See More →
Speakers
JA

Julie Armitstead

Principal Scientist, Pfizer, United States
avatar for Bryan Castle

Bryan Castle

Associate Vice President, Synthetic Molecule Design & Development, Eli Lilly and Company, United States
Dr. Castle is a technical leader in Eli Lilly & Company's Synthetic Molecule Design and Development organization. He has been part of the Lilly team for over 25 years and has held many different roles in drug substance and drug product analytical development. He currently is engaged... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement and advocacy for RA-CMC at Amgen Inc. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory harmonization including collaboration, regulatory... Read More →
GM

Gary McGeorge

Director for PAT, Bristol Myers Squibb, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Workshop

10:15am EDT

#516: Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing
Tuesday June 16, 2026 10:15am - 11:30am EDT
115C
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-563-L04-P; CME 1.25; RN 1.25This session explores the FDA and EMA’s evolving strategies to modernize nonclinical regulatory frameworks. We will examine both agency initiatives to reduce animal testing where scientifically appropriate and their roadmaps for increasing the regulatory acceptance of New Approach...
See More →
Speakers
avatar for Imein Bousnina

Imein Bousnina

Director, US Regulatory Policy, Product Development Regulatory, Genentech, A Member of the Roche Group, United States
Imein Bousnina, Pharm.D, is a Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Over her decade at Roche-Genentech, she has served as a subject matter expert and led the implementation of regulatory policy strategies on topics such as FDA and EMA's regulation... Read More →
avatar for Orla Moriarty

Orla Moriarty

Scientific Officer, European Medicines Agency, Netherlands
Orla Moriarty is a scientific officer in the Translational Sciences Office at EMA where she is responsible for providing scientific support to the Agency’s 3Rs and Non-clinical Working Parties. She joined EMA in 2023 as a Seconded National Expert from the Irish Health Products Regulatory... Read More →
avatar for Amanda Roache

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
HS

Haleh Saber

Deputy Director, DHOT/ OHOP/ CDER, FDA, United States
Dr. Saber is the Deputy Director in the Division of Hematology Oncology Toxicology (DHOT). In this role, she provides leadership for day-to-day activities, leads and coordinates scientific research, and participates in guidance development. Dr. Saber has extensive industry and regulatory... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Preclinical & Early Phase Research,Regulatory
  • Tags Forum

10:15am EDT

#517: Navigating the New FDA: Insights from Former FDA Chief of Staffs
Tuesday June 16, 2026 10:15am - 11:30am EDT
204AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-638-L04-P; CME 1.00; RN 1.00The session will feature former FDA Chief of Staffs discussing their contributions to regulatory policies, patient engagement, and innovative technologies, offering insights into the evolving regulatory landscape and helping stakeholders navigate FDALearning Objectives Identify key...
See More →
Speakers
avatar for Kalah Auchincloss

Kalah Auchincloss

Canal Row Advisors, United States
Kalah is a consultant to pharma, biotech and medical device companies providing strategic regulatory advice. Prior to her consulting and legal roles, Kalah spent six years at the FDA, including as Deputy Chief of Staff to Commissioner Robert Califf, and in senior positions in CDER’s... Read More →
avatar for Elizabeth Jungman

Elizabeth Jungman

Partner, Global Regulatory, Hogan Lovells US LLP, United States
Elizabeth Jungman is a Partner at the global law firm Hogan Lovells where she advises life sciences companies on high-stakes regulatory strategy and engagement with the FDA. Prior to joining Hogan, Elizabeth was FDA’s Chief of Staff, where she oversaw the day-to-day management of... Read More →
avatar for Elizabeth Lange

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

VP & Head, RQC, Science, Policy & Intelligence (SPI), Novo Nordisk Inc., United States
Elizabeth Rosenkrands Lange is an experienced R&D policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency and... Read More →
LS

Lauren Silvis

Senior Vice President, External Affairs, Tempus, United States
Lauren Silvis serves as Senior Vice President of External Affairs at Tempus, overseeing regulatory, public policy, government affairs and strategic communications. She has held a number of senior career public health roles, serving as a Senior Advisor at the Department of Health and... Read More →
JT

Julie Tierney

Principal, Leavitt Partners, United States
avatar for Susan Winckler

Susan Winckler

Chief Executive Officer, Reagan-Udall Foundation For the FDA, United States
Prior to accepting her post as CEO for the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

10:15am EDT

#519.1: European Integration in Times of Geopolitical Crisis: Supporting Ukraine’s EU Accession and Building Resilient Public Institutions
Tuesday June 16, 2026 10:15am - 11:30am EDT
105AB
Component Type: SessionLevel: IntermediateThis session will explore how Ukraine’s EU accession process is driving the transformation of its healthcare and pharmaceutical regulatory system during one of the most challenging geopolitical periods in modern European history. Speakers from the Ukrainian government, Poland, the European Medicines Agency, and the European Commission will discuss how...
See More →
Speakers
GC

Grzegorz Cessak

President, URPLWMIPB, Poland
MP

Magdalena Pajewska

Head of the International Relations Unit, Office For Registration of Medicinal Products, Medical Devices and Biocides, Poland
MS

Maryna Slobodnichenko

Deputy Minister, Ministry of Health of Ukraine, Ukraine
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

10:15am EDT

#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients
Tuesday June 16, 2026 10:15am - 11:30am EDT
115AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-564-L04-P; CME 1.25; RN 1.25Examines how fragmented policies, trade barriers, pricing pressures, and other restrictions create innovation gridlock—blocking or stalling R&D, delaying clinical trials, disrupting supply, and threatening patient access to critical therapies. Learning Objectives Identify key policy and...
See More →
Speakers
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
avatar for Michelle Rohrer

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech, A Member of the Roche Group, United States
Michelle Rohrer, PhD is Global Head of Product Development Regulatory at Genentech Roche. Michelle has worked at the company for 31 years, starting as a post-doctoral fellow. Michelle's awards include SF Business Times “The Most Influential Women in Bay Area Business” and PharmaVOICE... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   03: Data-Tech-AI, Forum

10:15am EDT

#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Tuesday June 16, 2026 10:15am - 11:30am EDT
117
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-567-L04-P; CME 1.25; RN 1.25See how different pharmaceutical companies use advanced analytics to augment traditional quality assurance methods, hear the Regulators’ perspective on use of innovative quality assurance methods.Learning Objectives Identify the different methods that are available to assure the...
See More →
Speakers
avatar for Jamie Bridges

Jamie Bridges

Executive Director, Clinical Quality Assurance, Merck Sharp & Dohme LLC , United States
Jamie Bridges has 26 years of pharmaceutical experience. She began her career at Pfizer and spent the past 25 years with Merck based out of West Point, PA. Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →
avatar for Kavita Dada

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
Captain Kavita Dada, Pharm.D., RAC (US), is Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She provides strategic leadership... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
avatar for Rachel Mead

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Rachel joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a GCP Inspector in July 2019. She conducts a wide range of routine and triggered GCP inspections across both commercial and non commercial organisations, including Phase 1 units registered under the MHRA... Read More →
avatar for Kiernan Trevett

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

10:15am EDT

#519: Patient Registries: Basket Trial or Basket Case?
Tuesday June 16, 2026 10:15am - 11:30am EDT
116
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-568-L04-P; CME 1.25; RN 1.25Akin to basket trials which study a single treatment for multiple conditions, patient registries enroll people with similar conditions, look for safe and effective treatments and disease management strategies, and are used to guide decision-making by clinicians, regulators and payers. Yet...
See More →
Speakers
avatar for Mike D'Ambrosio

Mike D'Ambrosio

Parexel, United States
22 Years Industry experience at top 5 CRO’s including in RWE/RWD general manager roles, leading RWE/RWD and medical affairs cross functional teams. Currently leads Parexel's Real World Research (RWD/RWE) business franchise - Helping customers build innovative RWD/RWE solutions to... Read More →
AD

Angela Dobes

SVP, IBD Plexus, Crohn's & Colitis Foundation, United States
Angela Dobes is the senior vice president of IBD Plexus, a real-world data platform and biorepository that redefines how researchers study inflammatory bowel disease to advance precision-medicine strategies and cut years off the R&D timeline. She strives to elevate the important role... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States
Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness... Read More →
avatar for Richard Gliklich

Richard Gliklich

Founder & Director, OM1, United States
Dr. Richard Gliklich is the Founder of OM1, Inc., a data, outcomes and technology company focused on using data and AI to accelerate medical research and improve clinical decision making. OM1 accelerates and lowers the cost of prospective and retrospective studies and registries for... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Data Management & Data Standards,Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum

11:30am EDT

#520 POS: Professional Poster Session II
Tuesday June 16, 2026 11:30am - 1:30pm EDT
Exchange
Component Type: Session

Professional Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
MB

Melissa Bechtel

Director, Expanded Access Strategy and Process Standards, Pfizer, United States
Melissa Bechtel is Director of Expanded Access, overseeing strategy and process standards for global and local programs that provide timely access to patients with serious or life-threatening conditions. She has worked in Expanded Access since 2015 and continues to expand her exp... Read More →
avatar for Walter Bender

Walter Bender

Chief Scientific Officer, Sorcero, Inc., United States
avatar for Esther Borteye

Esther Borteye

Risk Management Fellow, United States
Esther Borteye, PharmD, is a graduate of the University of Tennessee and currently serves as a Risk Management Fellow at Pfizer. She supports pharmacovigilance activities and Risk Evaluation and Mitigation Strategies across therapeutic areas, including assessing safety data, contributing... Read More →
JC

Joan Cheung

Principal Consultant, Epista Life Science, United States
Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs... Read More →
LC

Linda Chiou

Senior Manager Medical Information, LEO Pharma, United States
Linda Chiou is a Senior Medical Information Manager at LEO Pharma with more than 20 years of pharmaceutical industry experience. She is passionate about advancing Med Info through innovative uses of technology and AI to improve day-to-day operations, communication, and engagement... Read More →
AC

Adam Clarke

Innovation Manager, Bristol Myers Squibb, United States
Adam Clarke works on the Patient Safety Evolution team at Bristol Myers Squibb. He seeks to enhance collaboration, develop AI enabled safety, and develop digital health approaches that illuminate benefit–risk in new ways. He holds dual BS degrees in Chemistry and Biology and began... Read More →
avatar for Viviana Coppo

Viviana Coppo

IRB Principal Chair, WCG, United States
Viviana Coppo is a licensed pharmacist in the U.S. and Europe, with a Doctor of Pharmacy degree from the University of Turin. She has a strong background in the pharmaceutical industry, clinical research, and community pharmacy. She has over 20 years of experience in cross-functional... Read More →
avatar for Vamsidhara Dhulipala

Vamsidhara Dhulipala

Senior Director, Global Regulatory Affairs at GSK, GSK, United States
Vamsi currently works as a Senior Director, Regulatory Affairs at GSK. Prior to that Vamsi worked as a Director/Senior Director, Regulatory Affairs from 2013 to 2022 and as a toxicologist from 2004 o 2013 at Merck Research Labs. He has experience with all phases of drug development... Read More →
JD

John Diaz-Decaro

Founder, Black Swan Causal Labs, United States
John D. Diaz-Decaro, PhD, MS is a pharmacoepidemiologist and real-world evidence strategist with expertise in real-world evidence, observational study design, and AI-enabled evidence generation. He served as Senior Director and Lead Epidemiologist at ModernaTX, directing a global... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Principal Consultant, Decision Analytics, United States
Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory... Read More →
avatar for Karen Hinkle

Karen Hinkle

Associate Director, Medical Writing, Boehringer Ingelheim , United States
Karen Hinkle, Ph.D., is Associate Director of Medical Writing at Boehringer Ingelheim where she specializes in developing patient-facing regulatory documents for clinical trials, including Informed Consent Forms. She has a PhD in Physiology from the University of Michigan with a research... Read More →
avatar for Neda Jiveh

Neda Jiveh

Medical Information and Review Fellow, Pfizer, United States
avatar for MIDHUN RAJ K

MIDHUN RAJ K

Associate Director, Signal Management, IQVIA, India
Pharmacovigilance professional, with bachelor's in pharmacy and master's in data sciences with 15+ years of working experience in drug safety surveillance industry with a special focus on its quality management aspects. Worked with number of pharmaceutical, biological and medical... Read More →
RK

Rohit Kadam

Researcher, TCS ADD, TATA CONSULTANCY SERVICES LIMITED, INDIA, India
EK

Edward Kim

Analyst, FDA, United States
Edward is a clinical safety and surveillance research liaison and senior reviewer in the Office of Generic Drugs. He conducts and develops research and multifunctional projects to study drug safety and data-driven public health improvements. Prior to his nearly 17 years at FDA, Edward... Read More →
avatar for Hyeonmin Kwon

Hyeonmin Kwon

Assistant Manager, Korea Institute of Drug Safety and Risk Management (KIDS), Korea, Republic of
Hyeonmin Kwon is currently working at the Korea Institute of Drug Safety & Rist Management(KIDS) as a pharmacist. She earned a bachelor's degree in Pharmacy from Kangwon National University. Currently, she is part of the Office of ADR Relief, engaged in the causality assessment of... Read More →
avatar for Joseph Laudano

Joseph Laudano

Medical Director, IQVIA, United States
Joseph B. Laudano BS Pharm, Pharm D – Medical Director, IQVIA Inc. Joe has over 35 years’ experience in Pharma. Before joining IQVIA, he was VP, Medical Affairs at Pharmaspectra, VP Medical Affairs at Alliqua Biomedical and Senior Director of Medical Affairs & Global Head of Publication... Read More →
SL

SAMIR LEDADE

ASSOCIATE DIRECTOR, Alexion Pharmaceuticals, Canada
Samir Ledade is an Associate Director, Medical Writing Operations at Alexion Pharmaceuticals, based in Mississauga, Canada. He has over 16 years of experience in regulatory medical writing, clinical development, and pharmacovigilance within global pharmaceutical organizations. His... Read More →
PL

Po-Hung Lee

Associate Reviewer, Taiwan's Food and Drug Administration (TFDA), Taiwan
avatar for Ji Li

Ji Li

Reviewer, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Ji Li is a primary reviewer at the Division of Clinical Outcome Assessment at the U.S. FDA. Dr. Li reviews the use of clinical outcome assessments in IND/NDA/BLA applications that are intended to support labeling claims of medical product development programs. Dr. Li also reviews... Read More →
LL

Linghui Li

Associate Director, Takeda, United States
avatar for Anran Liu

Anran Liu

ORISE Postdoctoral Fellow, FDA, United States
Anran is a postdoctoral fellow at the U.S. FDA, CDER Office of Surveillance and Epidemiology, conducting research in pharmacovigilance and drug safety surveillance. She earned her PhD in Biostatistics from SUNY Buffalo in August 2024, where she developed approaches for adverse event... Read More →
avatar for ChiaPing Liu

ChiaPing Liu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Ms. Liu has received her bachelor degree in pharmacy from Taipei Medical University and later acquired her pharmacist certificate. She has received her master degree in Law from National Cheng Chi University. She has been serving in Taiwan Food and Drug Administration (TFDA) these... Read More →
KM

Kristi Malone

Lay Language & New Media Medical Writer, Boehringer Ingelheim, United States
Kristi is a lay language medical writer at Boehringer Ingelheim. She specializes in plain language regulatory writing including authoring informed consent documents. Kristi has more than 20 years of clinical trial experience in the pharmaceutical industry.
JM

Julia Mauro

Project Specialist, DIA, United States
avatar for Kristen Miller

Kristen Miller

Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA, United States
Kristen Miller is a Health Scientist Policy Analyst with the Office of Medical Policy (OMP) at the U.S. Food and Drug Administration (FDA), where she manages Real-World Evidence (RWE) Analytics for the Center of Drug Evaluation and Research (CDER). She oversees public-private collaborations... Read More →
avatar for Namareq Musa

Namareq Musa

Post-Doctoral Fellow, Pfizer, United States
PharmD graduate and a first-year U.S. Medical Information Post-Doctoral Fellow at Pfizer in Heme/Onc
avatar for Carolina Navas

Carolina Navas

COA Manager, IQVIA, Spain
I am an oncology scientist with training as a medical veterinarian and a PhD in Biochemistry and Molecular Biology, with over a decade of experience across academia and industry in Europe and the United States. I have contributed to multiple high-impact publications in oncology and... Read More →
JN

Jonathan Norman

Director, Localization & Scale Management, YPrime Inc., United Kingdom
IN

Isaac Nyarko

Senior Manager, Regulatory Affairs, Advertising and Promotion, Merz Aesthetics, United States
Isaac Nyarko, MS, MPH, is a Senior Manager of Regulatory Affairs, Advertising and Promotion, specializing in ad-promo compliance for pharmaceuticals and medical devices in the U.S. and Canada. He is currently pursuing a Doctorate in Regulatory Science at the University of Southern... Read More →
avatar for Feisal Othman

Feisal Othman

Benefit Risk Assessment Lead, Bristol Myers Squibb, United States
Feisal Othman is a drug safety and benefit–risk assessment professional with over 15 years of experience across healthcare, patient safety, and regulatory science. He currently serves as a Benefit Risk Assessment Lead at Bristol Myers Squibb, where he leads the development and application... Read More →
avatar for Sahishnu Patel

Sahishnu Patel

Associate Director, AI and Automation R&D, Synterex, United States
Sahishnu Patel, PhD, is Associate Director of AI and Automation R&D at Synterex, where he leads the design, validation, and responsible deployment of AI-enabled medical and regulatory solutions. His work focuses on building high-impact generative and agentic systems, advancing scalable... Read More →
AP

Amit Patel

CEO, Octozi, United States
Amit Patel is the co-founder and CEO of Octozi, an AI company automating clinical data workflows for pharma sponsors. Previously he was a product leader at GoogleX and Meta developing new AI platforms. He is a graduate of Stanford University and lives in New York City.
avatar for Su Qiu

Su Qiu

Director, Head of Medical Translation, Beone Medicines, China
Dr. Su Qiu is Director and Head of Medical Translation at BeOne Medicines. With over 15 years of experience in medical translation, Dr. Su has delivered high-quality simultaneous interpretation at more than 2,000 international medical conferences. She built BeOne Medicines’ in-house... Read More →
avatar for Mohit Raizada

Mohit Raizada

Director - Signal Management Services, IQVIA, India
Dr. Mohit Raizada is the Director and Head of Signal Management Services in the Lifecycle Safety department at IQVIA, India. He is an expert in signal management and has successfully onboarded, led, executed, and completed complex signal management projects for various companies... Read More →
AR

Anuradha Roy

Senior Vice President, One Vector, United States
A seasoned leader with 25+ years of experience advising clients on creating value through business transformation leveraging technology while keeping focus on compliance and quality. Anu started her career as a product manager, collaborating with different departments on scaling up... Read More →
avatar for Takahiro Sakai

Takahiro Sakai

Chief, Clinical Research Coordinating Section, National Cancer Center Hospital, Japan
JOB EXPERIENCE: April/2011 to present National Cancer Center Hospital East JAPAN(NCCHE) /Clinical Trial Management Office/Clinical Research Coordinator(CRC), chief EDUCATION: Master of Pharmacy QUALIFICATIONS: Association of Clinical Research Professionals(ACRP) certified CRC
ST

Steven Thompson

Founder, Nextrial AI, Brazil
CU

Chansonida Uk

Post-Doctoral Medical Affairs Fellow, CSL Seqirus/Northeastern University, United States
Chansonida J. Uk, PharmD, is a Post-Doctoral Medical Affairs Fellow at CSL Seqirus with over three years of experience across Medical Affairs, public health, and HealthTech. She has a strong background in immunology and vaccine science, supporting Medical Information, publications... Read More →
avatar for Yukino Umeki

Yukino Umeki

Reviewer (Biostatistics), Pharmaceuticals and Medical Devices Agency (PMDA), Japan
RV

Rishi Verma

Medical Director, Roche & Stethy, Australia
Rishi is a Physician and medical director who worked in the Life science industry. He has led and supervised various Clinical Trial programs across the world. Rishi is also the Director of Stethy an AI automation platform for the life science to improve safety and compliance across... Read More →
KY

Khaled Yahiaoui

Associate Director, Regulatory Affairs- Operations, Merck & Co., Inc., Canada
Khaled is Associate Director, Regulatory Operations at Merck Canada, with 16 years' experience in regulatory operations. He specializes in global electronic regulations, holds a Regulatory Affairs Certification from RAPS, and lectures on electronic submissions at the University of... Read More →
avatar for Takayuki Yasuda

Takayuki Yasuda

Statistical Programmer, Chugai Pharmaceutical Co., Ltd., Japan
Takayuki Yasuda has been serving as a Statistical Programmer in the Biometrics department at Chugai Pharmaceutical Co., Ltd. since 2020. He worked in the CRO industry from 2014 to 2020. Since 2024, he has been leading an initiative on implementing generative AI in the clinical development... Read More →
Tuesday June 16, 2026 11:30am - 1:30pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session

11:40am EDT

#521 CH: Achieving Representative Enrollment in Phase 3 Lupus Clinical Trials: A Case Study
Tuesday June 16, 2026 11:40am - 12:10pm EDT
Content Hub
Component Type: WorkshopLevel: IntermediateThis session covers the importance of representative enrollment in Phase 3 Lupus trials, Biogen’s approach to setting and achieving these goals, and how patient-focused strategies improve clinical trial integrity and outcomes.Learning Objectives 1. Understand the key challenges in representative enrollment in Phase 3 Lupus clinical trials. 2. Learn how...
See More →
Tuesday June 16, 2026 11:40am - 12:10pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

11:45am EDT

#522 IT: Artos, Inc Innovation Theater: AI Isn't About Generating Documents, it's About Generating Data
Tuesday June 16, 2026 11:45am - 12:15pm EDT
Innovation Theater 2
Component Type: SessionThe speakers will discuss how AI document generation is often a misunderstood problem. Sponsors focus on finding AI that can get words on a page, but they often lose sight of a broader, cross-functional, data strategy that this needs to fit within in order to achieve significant ROI. This discussion will provide a conversation around strategic adoption of AI and concrete...
See More →
Speakers
AA

Artos AI

United States
avatar for Josh Kim

Josh Kim

CEO, Artos AI, United States
Josh is the CEO and co-founder of Artos, which provides the AI-native document creation and management suite for drug development document creation and management. Prior to Artos, Josh worked in regulatory, clinical, and commercial strategy roles at Ignyta and Erasca where he focused... Read More →
avatar for Sean McNiff

Sean McNiff

Director, Regulatory Operations, Vertex Pharmaceuticals, Inc, United States
Tuesday June 16, 2026 11:45am - 12:15pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

11:45am EDT

#521.1 SS: Spark Stage: Patient Appreciation Session: Celebrating the Patient Voice
Tuesday June 16, 2026 11:45am - 12:45pm EDT
Spark Stage
Component Type: SessionThe Drug Information Association (DIA) is committed to advancing patient-centered healthcare through collaboration among patients and key stakeholders. This Patient Appreciation Session recognizes the vital contributions of patient advocates to healthcare innovation.Learning Objectives Recognize the impact of patient advocates on research, drug development, and healthcare...
See More →
Speakers
avatar for Maria Paula Bautista Acelas

Maria Paula Bautista Acelas

Scientific Program Manager, Research Partnerships, DIA, United States
Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →
avatar for Victoria DiBiaso

Victoria DiBiaso

Head of Patient Informed Development & Health Value Translation, Sanofi, France
Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Gloria Stone

Gloria Stone

Owner, G. Stone Connections, L.L.C., United States
Tuesday June 16, 2026 11:45am - 12:45pm EDT
Spark Stage The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  11: Spark Stage, Session

11:45am EDT

#523 IT: Syneos Health Innovation Theater: More Doesn't Guarantee Better - Why AI Success Depends on Organizational Agility, Not Just the Tech
Tuesday June 16, 2026 11:45am - 12:45pm EDT
Innovation Theater 1
Component Type: SessionAcross clinical development, a growing wave of AI tools is reshaping how work gets done, each designed to make processes faster, easier and more efficient. But in the rush to adopt AI, organizations can overlook the underlying sources of friction that limit performance. At the same time, reliance on monolithic platforms built for end-to-end standardization can limit...
See More →
Speakers
avatar for Matt Harrington

Matt Harrington

Global Head, Clinical Product, Syneos Technology Solutions, Syneos Health, United States
At Syneos Health, Matt is responsible for defining and delivering the clinical technology product strategy globally, including our AI enabled platforms that support study design, startup, execution and oversight. Matt joined Syneos Health in 2024. He has extensive clinical technology... Read More →
avatar for Syneos Health

Syneos Health

United States
Tuesday June 16, 2026 11:45am - 12:45pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#524 IT: Vivpro Corporation Innovation Theater: AI in Action - Scaling Regulatory Document Generation Across R&D
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: SessionAI is no longer a future consideration—it is actively reshaping how regulatory work gets done. Organizations that delay risk falling behind, while those that move early can gain a meaningful competitive edge. This session offers a practical, experience-driven perspective on how to operationalize AI for regulatory document generation. We will demonstrate how REGAIN enables...
See More →
Speakers
VC

Vivpro Corporation

United States
avatar for Joga Gobburu

Joga Gobburu

Co-Founder, Vivpro Corp, United States
Dr. Gobburu is a world-renowned scientific leader in the area of quantitative disease models and their applications to decisions. He is best known for transforming the field of pharmacometrics into a decision-supporting science. His experience as a senior biomedical research scientist... Read More →
avatar for Tushar Nitave

Tushar Nitave

Staff Software Engineer, Vivpro Corp, United States
Tushar Nitave brings over five years of data science and software engineering expertise to his role as a Staff Software Engineer at Vivpro Corp. He currently leads the engineering team for REGAIN, an AI-based solution for regulatory document creation, and holds a Master's in Computer... Read More →
avatar for Angela Winnier

Angela Winnier

Executive Director of Medical Writing, Pfizer, United States
Angela Winnier joined Pfizer in 2018 and is Executive Director of Medical Writing and the therapeutic area lead for internal medicine and inflammation/immunology. In addition to her pipeline support, Angela serves as technology lead for medical writing, providing strategic and operational... Read More →
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#525 IT: Yseop Innovation Theater: Design Regulatory Grade AI - Enable Scalable, Consistent Workflows Across Document Types
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 1
Component Type: SessionContent generation is easy. Delivering outputs that are accurate, traceable, and consistent enough for regulatory submission across diverse document types is not. As teams move beyond CSR into protocol, CMC, and pharmacovigilance workflows, many AI solutions fail to adapt, creating risk around compliance, scalability, and usability. This session explores what regulatory...
See More →
Speakers
avatar for Jenni Pickett

Jenni Pickett

Yseop, United States
Jenni Pickett, PhD, helps develop and deploy AI medical writing solutions for over a dozen large and small pharma companies as Head of Medical Writing for Yseop. She has 17 years of pharmaceutical industry experience, including 10 years of CMC experience and 7 years of regulatory... Read More →
avatar for Camille Sauder

Camille Sauder

Yseop, United States
With 10+ years in AI, Camille leads presales at Yseop, working directly with biopharma organizations on scoping and implementing AI solutions across complex workflows. Over 8 years at Yseop, she has held roles spanning AI technical consultant, project management, and customer success... Read More →
avatar for Yseop

Yseop

United States
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:30pm EDT

#526 RT: Roundtable Discussion: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Tuesday June 16, 2026 12:30pm - 1:30pm EDT
Zone A
Component Type: SessionLevel: IntermediateJoin the Statistics & Data Science Community for a follow up round table discussion tied to session: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis (Tuesday, June 16 | 12:30pm - 1:30pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Matthew...
See More →
Tuesday June 16, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:05pm EDT

#527 IT: Certara Innovation Theater: LLM-Driven Submissions: From Data Preparation to eCTD
Tuesday June 16, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: SessionWhen introducing efficiencies to your regulatory workflow, it’s not simply a question of writing faster. Teams need to look up and down stream to accelerate data delivery, automate consistent first drafts and enable faster eCTD preparation. This session presents a practical, framework for regulatory submissions that connects data pipelines and GenAI-assisted authoring with...
See More →
Speakers
avatar for Certara

Certara

United States
avatar for Liam O'Leary

Liam O'Leary

Client Solutions Architect, Certara, United States
Liam O’Leary is a Client Solutions Architect at Certara.AI, applying GenAI to bridge science and software for life-sciences teams. He has delivered over 50 CoAuthor demonstrations for pharmaceutical and biotech companies, developed training and workflows for regulatory writers... Read More →
Tuesday June 16, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:45pm EDT

#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB
Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-569-L04-P; CME 1.25; RN 1.25This session explores pharmacovigilance for biosimilars, focusing on how FDA’s suffix-based naming and surveillance are implemented in practice. Panelists from FDA, academia, and industry will discuss suffix-related challenges and future directions.Learning Objectives Describe the FDA’s...
See More →
Speakers
avatar for Mary Jo Carden

Mary Jo Carden

Carden Associates, United States
Mary Jo Carden is President of Carden & Associates. She previously served as Head of Policy at Sandoz, Inc., Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities... Read More →
avatar for Judith Maro

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States
Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →
avatar for Stacey Ricci

Stacey Ricci

Director, Scientific Review Staff, OTBB, CDER, FDA, United States
As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars (U.S.FDA/CDER), Dr. Ricci leads a team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar products at all stages of development, advance... Read More →
avatar for Mariana Socal

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

1:45pm EDT

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108A
Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-654-L04-P; CME 1.25; RN 1.25This session summarizes the work of the DIA Obesity Consortium with focus on the agreements that have been reached about which are the endpoints that should be included in Phase 3 clinical trials for the development of obesity drugs. The work is a result of the discussions among 10...
See More →
Speakers
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States
Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →
AM

Alison Matsui

Senior Principal PCOR Scientist, Genentech, A Member of the Roche Group, United States
KR

Katherin Ruiz

Consultant, Global Scientific Communications, Eli Lilly and Company, United States
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session
  • Audience Advanced
  • Area Therapeutic Pathways
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Therapeutic Pathways
  • Tags Session

1:45pm EDT

#531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
107AB
Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-571-L04-P; CME 1.25; RN 1.25Update on a DIA study advancing patient experience data to assess tolerability in immuno-oncology trials, highlighting conceptual model progress and stakeholder insights for regulatory decisions.Learning Objectives Describe recent developments from the DIA study integrating patient...
See More →
Speakers
avatar for Maria Paula Bautista Acelas

Maria Paula Bautista Acelas

Scientific Program Manager, Research Partnerships, DIA, United States
Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration... Read More →
avatar for Efrat Dotan

Efrat Dotan

Executive Medical Director, Ann B Barshinger Cancer Institute, Lancaster General, Penn Center for Cancer Care Innovation, United States
DP

Devin Peipert

Professor of Health Outcomes Measurement, University of Birmingham, United Kingdom
Prof Peipert holds a 125th Anniversary Chair in the Department of Applied Health Sciences at the University of Birmingham, where he is affiliated with the Centre for Patient Reported Outcomes Research (CPROR) and the Birmingham Health Partners Centre for Regulatory Science and Innovation... Read More →
avatar for Lia Ridout

Lia Ridout

Patient Advocate, -, United States
Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →
AR

Angela Rylands

Global Head of Patient Centred Outcomes, Kyowa Kirin, United Kingdom
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

1:45pm EDT

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108B
Component Type: SessionLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P; CME 1.25; RN 1.25This pilot explored using synthetic AI patient personas to review clinical trial materials when real patient input was challenging due to time pressure. Alignment with actual patient feedback and potential for scalability was demonstrated.Learning Objectives Describe how synthetic AI patient...
See More →
Speakers
JB

Jason Binder

Founder & CEO, Ember, United States
Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →
avatar for Sabina Kineen

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
HM

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany
RW

Robina Weermeijer

Boehringer Ingelheim, Netherlands
Robina Weermeijer is a Trial Patient & Site Engagement Lead within Global Clinical Development Operations, based in Amsterdam. With a strong focus on enhancing patient and site experiences in clinical trials, she works to elevate patient and site voices. In addition, she plays a key... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session

1:45pm EDT

#532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
109AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-572-L04-P; CME 1.25; RN 1.25This session explores strategies to implement AI, cloud, and different data sources across the drug lifecycle and in regulatory activities to deliver patient benefits. Experts will discuss pilots, policies, and partnerships that can enable faster access to safe and effective...
See More →
Speakers
KB

Kimberly Beer

Senior Vice President, Policy & External Affairs, National Health Council, United States
Kimberly Beer is Senior Vice President of Policy and External Affairs at the National Health Council, where she leads policy and advocacy to improve access to affordable, high-quality care for people with chronic conditions and disabilities. She previously served as Senior Director... Read More →
avatar for Rebecca Nebel

Rebecca Nebel

Deputy Vice President, Science and Regulatory Advocacy, Phrma, United States
Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →
avatar for Rebecca Nebel

Rebecca Nebel

Deputy Vice President, Science and Regulatory Advocacy, Phrma, United States
Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →
avatar for Rebecca Nebel

Rebecca Nebel

Director, Global Regulatory Policy and Intelligence, Amgen, United States
Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →
avatar for Andrew Robertson

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →
avatar for Jonathan Walsh

Jonathan Walsh

Chief Scientific Officer, Unlearn.AI, United States
Jon Walsh is the co-founder and Chief Scientific Officer of Unlearn.AI and a physicist by training. At Unlearn, Jon leads the integration of digital twins into drug development, with a particular focus on regulatory pathways and the intersection of statistics and machine learning... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

1:45pm EDT

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
111AB
Component Type: SessionLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-573-L04-P; CME 1.25; RN 1.25AI pilots are everywhere; enterprise impact is rare. Governance separates AI that works once from AI that works reliably. Join pharma, regulator, and tech leaders to explore how data ownership, content models, and process controls enable trustworthy AI.Learning Objectives Explain why scalable...
See More →
Speakers
avatar for Vanni Carapetian

Vanni Carapetian

Senior Director, Regulatory Data, Genentech, A Member of the Roche Group, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Vanni Carapetian

Vanni Carapetian

CMC RA, Strategy and Operations, Executive Director, Gilead Sciences, Inc, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
avatar for Andrew Robertson

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →
JS

Jeff Steinke

Founder, TE Digital Limited, United Kingdom
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

1:45pm EDT

#535: Unlock AI's Full Potential: The Power of FAIR Data
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
119AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-574-L04-P; CME 1.25; RN 1.25AI underperforms when data isn’t machine-actionable. This talk shows how FAIR + open standards turn fragmented R&D data into fuel for LLMs and analytics—via a mini-rubric, case studies, and a 90-day roadmap to lift AI-readiness.Learning Objectives Apply a mini-FAIR rubric to one...
See More →
Speakers
KH

Kaveen Hiniduma

Graduate Research Associate, Ohio State University, United States
KR

Kathleen Rand

Principal Scientist, Procter & Gamble, United States
avatar for Ted Slater

Ted Slater

Global Head, Knowledge Engineering & Data Advisory, EPAM Systems, United States
My work focuses on FAIR Data and the application of semantic technologies and artificial intelligence to scientific problems in pharmaceutical R&D and related fields. I am a molecular biologist and a computer scientist.
AU

Anuj Uppal

Vice President, Life Sciences Transformation, Campana & Schott, United States
Anuj Uppal is a data scientist and AI product leader at Campana & Schott who builds intelligent platforms that transform how life sciences organizations assess data readiness. His creation, DATA Compass, challenges the industry assumption that "clean data" equals "AI-ready data"—a... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

1:45pm EDT

#534: The Best Pitch Advice I Ever Got: How to Nail Main Stage Talks, Pitch Decks, and Any Talk of a Lifetime
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
103A
Component Type: WorkshopLevel: IntermediateIn this interactive workshop, coach Jeff Smith shares essential building blocks – Prep as Empathy, the Impact Wave, Visuals on Purpose, and Dynamic Delivery – used to shape “talks of a lifetime,” from founding pitch decks to keynote and TED stages.Learning Objectives Use preparation as an empathy tool to align with enterprise/pharma stakeholders;...
See More →
Speakers
JS

Jeff Smith

The Curator, Smith and Jones Innovation, United States
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Workshop |   06: ProfDevelop-Program-PortfolioMgmt, Workshop |   18: Lift-Series, Workshop

1:45pm EDT

#536: Project Management as a Catalyst for Enterprise Transformation
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
202AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-575-L04-P; CME 1.25; PDU 1.25 PMI 21662N25CW; RN 1.25Project Management as a Catalyst for Enterprise Transformation explores how Project Management (PM) drives strategic alignment, organizational evolution, and long-term sustainment across the enterprise. This session will examine how PM-led governance and...
See More →
Speakers
JO

Joann O'Connor

Executive Director, Head of Pipeline Project Management for BD and Alliances, GSK, United States
Joann O’Connor is a pharmaceutical R&D leader with 20 years of drug development experience spanning research, development, and commercialization. She is Executive Director, Head of Pipeline Project Management for Business Development and Partnerships at GSK, where she leads a specialized... Read More →
avatar for Jayanthi Reddy

Jayanthi Reddy

Eikon Therapeutics, Head of Project and Portfolio Management, United States
Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.
avatar for Elizabeth Somers

Elizabeth Somers

Associate Vice President, Global Project and Alliance Management, Merck & Co., Inc., United States
Liz is an Associate Vice President in Global Project and Alliance Management at Merck leading a large team that is focused on end to end drug development Project Management in the therapeutic areas of Imm, Neuro, CV, ID/Vaccines and Ophthalmology. She has direct experience managing... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Interest Area Project Management & Strategic Planning
  • Tags Workshop

1:45pm EDT

#537: EMA Town Hall
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
204AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-670-L04-P; CME 1.25; RN 1.25In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.Learning Objectives Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the...
See More →
Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Ana Trullas

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands
Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

1:45pm EDT

#538: Innovations in Drug Review: A Global Perspective
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
201AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-579-L04-P; CME 1.25; RN 1.25This roundtable will discuss innovations in drug review, including real-time review, AI-enabled dossier analysis, cloud data exchange, mid-cycle communications, and cross-disciplinary review, and how modern tools create a dynamic review environment.Learning Objectives Examine drug review...
See More →
Speakers
avatar for Donna Boyce

Donna Boyce

Senior Vice President & Head, Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for Cartier Esham

Cartier Esham

Chief Scientific Officer, Biotechnology Innovation Organization (BIO), United States
Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which... Read More →
RH

Rhonda Hearns-Stewart

Senior Physician, FDA, United States
Rhonda Hearns-Stewart, MD, is a Senior Physician. She joined the FDA as a Medical Officer in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) in 2013. As a senior clinical reviewer in the Division of Bone, Reproductive, and Urologic Products... Read More →
avatar for Brittany McKelvey

Brittany McKelvey

Senior Director, Regulatory Policy, LUNGevity Foundation, United States
Brittany McKelvey is the Senior Director of Regulatory Policy at the LUNGevity Foundation. In her role, she leads the organization in advancing lung cancer policy, clinical trial reform, and regulatory initiatives. Brittany directs the Transforming Clinical Trials Initiative, fostering... Read More →
avatar for Max Wegner

Max Wegner

Senior Vice President,Head Regulatory Affairs, Bayer, Germany
A global leader in regulatory science, Max Wegner is Senior Vice President and Head of Regulatory Affairs at Bayer, overseeing all regulatory activities for the Pharmaceuticals division. He began his career in pharmacy at the University of Bonn, continued his pharmacology PhD at Bayer... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

1:45pm EDT

#540: Regulators Approach to Address Drug Shortages
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115C
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-578-L04-P; CME 1.25; RN 1.25Drug shortages are difficult to measure across healthcare systems and complex pharmaceutical supply chains. At this session, the FDA and their international regulatory counterparts will address the key aspects of drug shortages in their region and how real-world data are used to inform on...
See More →
Speakers
avatar for Grace Chai

Grace Chai

Associate Director for Special Initiatives, OSE, CDER, FDA, United States
avatar for Sema Hashemi

Sema Hashemi

Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
ET

Emily Thakur

Team Leader, Drug Shortage Staff, Office of the Center Director, CDER, FDA, United States
CDR Emily Thakur has been working with the Drug Shortage Program since February 2011. She joined the FDA in 1999, working in the Office of Generic Drugs. She then joined the Office of Regulatory Policy in 2005. She received her Bachelor of Science degree from Rutgers College of Pharmacy... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

1:45pm EDT

#541: Taiwan Town Hall: Strategies to Promote Medicine Supply Resilience
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
112AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-669-L04-P; CME 1.25; RN 1.25This Taiwan Town Hall showcases Taiwan’s evolving approach to medicine supply resilience. It brings together regulators, industry, and health systems from Taiwan, the EU, Japan, and the US to explore coordinated global pathways for critical medicines.Learning Objectives Explain...
See More →
Speakers
avatar for Chih-Kang Chiang

Chih-Kang Chiang

Director General, Taiwan Food and Drug Administration, Taiwan
Dr. Chiang has been the Director General of Taiwan Food and Drug Administration (TFDA) since February 27, 2025. He oversees the regulation of food, drugs, medical devices, and cosmetics. Prior to the DG of TFDA, Dr. Chiang was a highly accomplished professional serving as the Director... Read More →
avatar for Matt Eberts

Matt Eberts

Senior Director System Pharmacy Business and Outcomes, University of Maryland Medical System, United States
Matt is the Senior Director of System Pharmacy Business and Outcomes for the University of Maryland Medical System (UMMS). In his role he is responsible for the medication supply chain, centralized distribution, and business functions for the 12 hospital health care system.
avatar for Masaya Tamae

Masaya Tamae

Deputy General Manager, Corporate Strategy Division, Meiji Seika Pharma., Co., Ltd, Japan
avatar for Meng-Hsiu Wu

Meng-Hsiu Wu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

1:45pm EDT

#539: Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-577-L04-P; CME 1.25; RN 1.25Explore how patient-focused principles can transform product labeling into a strategic asset. Learn how to integrate patient perspectives early, align with regulatory trends, & leverage labeling to support decision-making and differentiate products.Learning Objectives Identify...
See More →
Speakers
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →
avatar for Julie Guery

Julie Guery

Global Regulatory Affairs Labeling Head, Sanofi, United States
Julie Guery is the Global Regulatory Affairs Labeling Head at Sanofi, leading a team of 50+ professionals focused on Labeling Strategy, Innovation, and Operations. She supports a broad portfolio across Inflammatory & Immunology, Rare Diseases, Oncology, Vaccines, and General Medicine... Read More →
JH

Jason Harris

Vice President, Government Relations and Advocacy, National Psoriasis Foundation, United States
KI

Kaisa Immonen

Patient and Consumer Liaison, European Medicines Agency, Netherlands
Kaisa Immonen joined the Stakeholders and Public engagement team of the European Medicines Agency (EMA) in 2023. She supports interactions with patients, consumers and their organisations. Kaisa holds a Master’s degree in Health Policy, Management and Innovation (Maastricht University... Read More →
avatar for Kelly Treonze

Kelly Treonze

Head, Global Labeling, Merck & Co., Inc., United States
Kelly M. Treonze, MS, Head, Global Labeling, Merck & Co., Inc. Kelly leads Global Labeling at Merck which is part of Global Regulatory Affairs and Clinical Safety. In this role, Kelly leads a team of 80+ labeling professionals who support the labeling strategy and development for... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   04: MedAffairs-SciComm, Forum

1:45pm EDT

#542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
117
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-580-L04-P; CME 1.25; RN 1.25This forum will present: 1) HA expectations related to cross-functional QbD, 2) Specific examples will highlight the change need for traditional clinical trial functions to meet QbD requirements.Learning Objectives Explain Health Authority (HA) expectations for cross-functional Quality by...
See More →
Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

1:45pm EDT

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116
Component Type: ForumLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P; CME 1.25; RN 1.25Bayesian statistical methods are gaining increasing importance in drug development, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on...
See More →
Speakers
JJ

Juan Jose Abellan

Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
avatar for May Mo

May Mo

Associate Vice President, Biostatistics, Amgen, United States
May Mo is an Associate Vice President of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal platform organization with specialized statistical expertise in areas such as Innovative... Read More →
AT

Andrew Thomson

Consultant, Regnitio, Netherlands
Dr Thomson is a consultant providing expert advice on clinical trial design, analysis and interpretation. He spent over 18 years as a regulator in the EU system, where he held a variety of quantitative roles, initially at the UK regulator, MHRA and subsequently at EMA. In his time... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Advanced
  • Area Global Alignment in Practice
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Global Alignment in Practice
  • Tags Forum

3:15pm EDT

#546 IT: Collate Innovation Theater: A Thousand Document Types - An AI Platform Approach to Document Authoring and Intelligence Adopted by Global Enterprises
Tuesday June 16, 2026 3:15pm - 3:45pm EDT
Innovation Theater 1
Component Type: Session



Chair

Collate

Speaker

Speaker
Surbhi Sarna


Speakers
C

Collate

United States
avatar for Surbhi Sarna

Surbhi Sarna

CEO, Collate, United States
Surbhi is the CEO and Founder of Collate. Previously, she was the CEO and Founder of nVision Medical, a medical device company that developed a novel method for the early detection of ovarian cancer, which was acquired by Boston Scientific for $275 million. She has served as a board... Read More →
Tuesday June 16, 2026 3:15pm - 3:45pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

3:15pm EDT

#544 RT: Roundtable Discussion: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone B
Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust (Tuesday, June 16 | 3:00pm - 4:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Atika Kumar, MBA, MS

Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:15pm EDT

#545 RT: Roundtable Discussion: Regulators Approach to Address Drug Shortages
Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone A
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Regulators Approach to Address Drug Shortages (Tuesday, June 16 | 3:15pm - 4:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick

Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

4:15pm EDT

#547: Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118AB
Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-582-L04-P; CME 1.00; RN 1.00A forum sharing different perspectives from international regulators & patients on when is the right time to publish information on safety signals from spontaneous data. We will explore how we can meet patient needs without leaving unanswered questions.Learning Objectives Discuss the challenges...
See More →
Speakers
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre (UMC), Sweden
Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →
MM

Michael Mittelman

Chairman, American Living Organ Donor Fund, United States
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
avatar for Lisa Wolf

Lisa Wolf

Deputy Director, Division of Pharmacovigilance I, OSE, CDER, FDA, United States
Dr. Lisa Wolf joined the Division of Pharmacovigilance-I (DPV-I), Center for Drug Evaluation and Research, US Food and Drug Administration in 2016, where she served as a Safety Evaluator for gastroenterology products, followed by Team Leader covering multiple therapeutic areas, and... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Forum
  • Audience Basic
  • Area Patient-Centered Design and Experience
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
  • Feature Topics Patient-Centered Design and Experience
  • Tags Forum

4:15pm EDT

#548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108A
Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-584-L04-P; CME 1.00; RN 1.00This pilot project aimed to upskill community cancer centers to carry out clinical trials. ACCC and ACRP identified needs and provided self-study and instructor-led training that improved learner knowledge and confidence. Learning Objectives Describe the challenges faced by research-naïve and...
See More →
Speakers
avatar for Ruma Bhagat

Ruma Bhagat

Process Excellence Leader, Genentech, A Member of the Roche Group, United States
avatar for Pete Fronte

Pete Fronte

Founder and Chief Executive Officer, Altura, United States
Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within primary care organizations and community... Read More →
avatar for Susan Landis

Susan Landis

CEO, Association of Clinical Research Professionals (ACRP), United States
Susan Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Susan led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI). While at Duke, Susan established and led... Read More →
avatar for David Vulcano Landis

David Vulcano Landis

CEO, Association of Clinical Research Professionals (ACRP), United States
David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards and initiatives. He currently serves as the Chief Executive Officer of the Association of Clinical Research Professionals and previously served as the Vice... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

4:15pm EDT

#549: Reimagining Site Source: Optimizing Clinical Trial Execution for Sponsors, Sites, and Patients
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108B
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-583-L04-P; CME 1.00; RN 1.00This session is intended to show how modern site source and integrated site solutions connect data, people, and processes to create a more efficient, future-ready clinical trial ecosystem. Learning Objectives Discuss the evolving role of site source in optimizing trial execution and...
See More →
Speakers
avatar for Jonathan Andrus

Jonathan Andrus

CEO, CRIO, United States
With 30 years of experience, Jonathan specializes in developing eClinical services that integrate data and technology to optimize study execution. At CRIO, he oversees customer success, sales, marketing, finance, compliance, and people programs. An active thought leader, Jonathan... Read More →
avatar for Melissa Gottschlich

Melissa Gottschlich

Senior Director Site Network, Accellacare, United States
Melissa “Missy” Gottschlich is Senior Director, Site Network at ICON, where she leads global strategy and centralized operations for Accellacare, ICON’s proprietary clinical site network. She oversees cross-functional teams spanning technology, finance, quality, project management... Read More →
SJ

Samir Jain

Head of EHR and Interoperability Solutions, Medidata, a Dassault Systèmes Company, United States
Samir Jain is the Head of EHR and Interoperability Solutions at Medidata, driving the company's healthcare interoperability strategy. With over 20 years in health tech, he previously built EHRs and led interoperability at Allscripts, developed large-scale Health Information Exchanges... Read More →
AV

Aneesh Vaze

Managing Director, Clinical Research of Philadelphia, United States
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Tags Forum

4:15pm EDT

#550: Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
109AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-586-L04-P; CME 1.00; RN 1.00This session examines evolving US and EU regulatory approaches to AI in drug development and explores how policy expectations are translated into real world GxP implementation. Attendees will gain insight into regulatory convergence, operational challenges, and good practices for...
See More →
Speakers
avatar for Martin Heitmann

Martin Heitmann

Volunteer – ISPE GAMP Guide Artificial Intelligence Co-Lead, Secretary of the GA, International Society for Pharmaceutical Engineering (ISPE), Germany
Martin Heitmann is a trained business mathematician and serves as consultant and advisor to organizations in the Life Sciences. He holds a decade of experience focusing on technology, innovation, and transformation. He drives progress and inspires excellence in life sciences, while... Read More →
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Luis Pinheiro

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands
Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce at the European Medicines Agency. He is a rapporteur for the AI workstream of the NDSG Data and AI Workplan, with a special focus on Guidance Development. He coordinates the Health Data... Read More →
JW

Junyang Wang

Global Regulatory and Scientific Policy, EMD Serono, United States
Junyang Wang, MSc has over 15 years of public health experience and over a decade of combined regulatory policy and stakeholder engagement experiences across drugs, devices, and digital. He currently serves as Director for US Global Regulatory and Scientific Policy (GRASP) at EMD... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

4:15pm EDT

#551: Operationalizing Large Language Models in Drug Development
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
111AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-585-L04-P; CME 1.00; RN 1.00Generative AI and large language models (LLMs) are reshaping drug development and Real-World Evidence (RWE). This session explores real-world applications, debunks common myths, and outlines what’s needed for safe, scalable, and compliant use across the drug development...
See More →
Speakers
WA

Wesley Anderson

Scientist, Quantitative Medicine, Critical Path Institute, United States
Wes Anderson, Ph.D. is a Quantitative Medicine Scientist at the Critical Path Institute, where he develops data-driven solutions to support drug development using machine learning, artificial intelligence, natural language processing, and informatics. He has also contributed to the... Read More →
DB

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States
DB

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States
Dr. Danielle Boyce is Principal Investigator of Real World Evidence at the ALS Therapy Development Institute and a faculty member at Johns Hopkins University, with affiliations at the University of Calgary, University of Chicago, and Emory University. A mother of a child with rare... Read More →
EN

Emily Nieves

CEO/ Co-Founder, Delineate, United States
Emily Nieves is the co-founder and CEO of Delineate, a seed-stage startup partnering with pharmaceutical companies to accelerate Model-Informed Drug Development workflows through advanced AI techniques. Prior to founding Delineate, Emily pursued graduate studies in Biological Engineering... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session

4:15pm EDT

#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-587-L04-P; CME 1.00; RN 1.00This session explores how lean authoring streamlines clinical regulatory documents, debunks myths about reviewer preferences, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.Learning Objectives Identify common...
See More →
Speakers
LG

Lauren Geary

Senior Director, GSC, Regulatory Writing and Submission Capabilities, Eli Lilly and Company, United States
As the Sr. Director of Regulatory Capabilities and Submissions at Eli Lilly, I am responsible for ensuring functional proficiency in regulatory medical writing. Leveraging my medical training at the USC Keck School of Medicine, and regulatory training and experience in clinical trial... Read More →
avatar for Inger Nielsen

Inger Nielsen

Associate Director, Novo Nordisk A/S, Denmark
Inger Ødum Nielsen is Associate Director in Content Innovation and Management, Clinical Reporting at Novo Nordisk, where she leads a team focused on driving digital transformation in clinical reporting. She has a strong track record of operationalising digital tools into the line... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication,Regulatory
  • Tags Session

4:15pm EDT

#563: Oncology Pathways Under Pressure: From CAR-T Access Today to Longevity-Driven Care Tomorrow
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
107AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-655-L04-P; CME 1.00; RN 1.00By placing CAR-T within a broader trajectory—from breakthrough therapies today to longevity-driven oncology tomorrow—this session challenges stakeholders to rethink how access, value, and sustainability must evolve to keep pace with scientific progress.Learning Objectives Assess...
See More →
Speakers
RD

Ronald DePinho

Professor, Cancer Biology, The University of Texas MD Anderson Cancer Center, United States
avatar for Laura Okpala

Laura Okpala

Executive Director, Head of US Reimbursement Policy, Gilead Sciences, United States
At Gilead Sciences, Laura leads the US reimbursement policy team focused on driving access to innovative medicines across Gilead’s oncology and virology portfolio, including reimbursement strategies for Kite Pharma, a leader in the development of novel CAR T therapies. Laura joined... Read More →
avatar for Bradley Watts

Bradley Watts

Patient/Industry Advocate and Vice President, Business Development Executive, Emily Whitehead Foundation and Conner Strong & Buckelew, United States
Brad Watts is a cancer survivor and CAR-T therapy recipient, Brad is an active advocate with The Emily Whitehead Foundation and Blood Cancer United, and is a member of Act for Hope, which is working to expand patient access by collaborating across the healthcare ecosystem. Drawing... Read More →
avatar for Tom Whitehead

Tom Whitehead

Co-Founder and President, Emily Whitehead Foundation, United States
Tom Whitehead President & Co-founder, Emily Whitehead Foundation Tom Whitehead is a keynote speaker, author, and journeyman lineman for an energy company. He is also the proud father of Emily and the co-founder of the Emily Whitehead Foundation, which is dedicated to raising awareness... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

4:15pm EDT

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-588-L04-P; CME 1.00; RN 1.00Explore the latest combination product trends, sustainability in design, recent FDA/global guidelines, post-approval device changes, and emerging submission practices to help navigate the evolving regulatory landscape and achieve development success.Learning Objectives Discuss recent FDA...
See More →
Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →
KD

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States
Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk A/S, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

4:15pm EDT

#554: Reverse Pitches: How Pharma Actually Buys
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
103A
Component Type: SessionLevel: AdvancedFounders pitch to pharma expecting a straightforward evaluation, but pharma doesn't buy the way VCs do. Led by Whale Tank judges and biopharma thought leaders, this session flips the script—showing how pharma actually evaluates, negotiates, and commits to partnerships with innovative companies.Learning Objectives Identify the hidden criteria and...
See More →
Speakers
avatar for Ligia Kilinski Cevasco

Ligia Kilinski Cevasco

BioPharma Consultant, Ligia Kilinski-Cevasco, Inc., United States
MG

Mindy Gruba

Associate Director, Clinical Trial Digital Health, Moderna, United States
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   18: Lift-Series, Session

4:15pm EDT

#555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C
Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-589-L04-P; CME 1.00; RN 1.00This forum will address the rise of illegal mass manufacturing of unapproved medicines, which threatens patient safety. Participants will discuss current regulations and the need for new rules to ensure drug supply chain integrity and promote safety.Learning Objectives Describe the landscape...
See More →
Speakers
avatar for Andrew Funk

Andrew Funk

Director, Member Relations/Government Affairs, NABP, United States
Andrew Funk, PharmD, Director of Member Relations and Government Affairs, NABP Andrew Funk is the Director of Member Relations and Government Affairs for the National Association of Boards of Pharmacy (NABP). With more than a decade of experience in pharmacy regulation—including... Read More →
RL

Renato Lopes Hurtado

head the Management of Inspection and Health Surveillance of Medicines and Pharm, ANVISA, Brazil
Manager of the Medicines and Pharmaceutical Ingredients Inspection Department (GIMED) at Anvisa, the Brazilian Health Regulatory Agency. A pharmacist with a Master’s and a PhD candidate (UnB), he is a certified Lead Auditor (ISO 9001/19011). His career features extensive experience... Read More →
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
SS

Shabbir Safdar

Executive Director, Partnership for Safe Medicines, United States
Shabbir Imber Safdar is the executive director of the Partnership for Safe Medicines and hosts the True Crime and Medicine Safety and the Imitation Nation "all things counterfeit" podcast. He sits on the editorial board of the Journal of Illicit Trade, Financial Crime, and Compliance... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session

4:15pm EDT

#556: Access Consortium Town Hall
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
201AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-594-L04-P; CME 1.00; RN 1.00The session will showcase the new Access Consortium’s GROWTH Manifesto and the resulting opportunities. It will also provide an update one year after publishing the Access Strategic plan, highlighting our achievements in speeding up approvals through work-sharing initiatives. Learning...
See More →
Speakers
avatar for Pamela Aung-Thin

Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada
Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.
avatar for Raymond Chua

Raymond Chua

Deputy Director of Medical Services, Health Regulation Group, Ministry of Health, Singapore
Adj A/Prof (Dr) Raymond Chua is a Registered Medical Practitioner and Public Health Specialist. He is currently the Deputy Director of Medical Services, Health Regulation Group to oversee the regulations of healthcare services and premises in Singapore, so as to safeguard public health... Read More →
avatar for Anthony Lawler

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →
avatar for Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
VT

Vincenza Trivigno

Executive Director of Swissmedic, SwisMedic, Switzerland
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

4:15pm EDT

#557: Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-591-L04-P; CME 1.00; RN 1.00This session will explore scientific and regulatory considerations unique to cell and gene therapies (CGTs), emphasizing the urgent need for harmonization among health authorities globally. Participants will discuss regulatory challenges and examine opportunities for regulatory...
See More →
Speakers
avatar for Andrew Byrnes

Andrew Byrnes

Director, Division of Gene Therapy 1, CBER, FDA, United States
Andrew P. Byrnes, PhD, is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing... Read More →
DA

D. Allen Callaway

Associate Director - Global Regulatory Affairs CMC, Johnson and Johnson, United States
avatar for Patrick Celis

Patrick Celis

Scientific Administrator, European Medicines Agency, Netherlands
Patrick Celis joined the European Medicines Agency (EMA) in 1997. He holds a degree in Pharmacy and a PhD in Pharmaceutical Sciences. P Celis is Lead Scientific officer in EMA’s ATMP Office and since December 2008, he is responsible for the Scientific Secretariat of the Committee... Read More →
avatar for Akanksha Kaushal

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States
Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

4:15pm EDT

#560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-590-L04-P; CME 1.00; RN 1.00Novel endpoints, biomarkers, and digital tools offer transformative potential but face regulatory acceptance challenges. Explore current landscape, successful case studies, and strategies for enhanced regulatory engagement through collaboration.Learning Objectives Discuss the current FDA...
See More →
Speakers
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Vice President, Regulatory Policy, BridgeBio, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Valerie Parker

Valerie Parker

Assistant Research Director, Duke-Margolis Institute For Health Policy, United States
Valerie J. Parker is an Assistant Research Director at the Duke-Margolis Institute for Health Policy. Valerie manages one of the institute’s cooperative agreements with the US FDA as well as oversees a core workstream of the institute’s Real-World Evidence Collaborative, where... Read More →
avatar for Lauren Tobe

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 13+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

4:15pm EDT

#559: China Town Hall
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
202AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-592-L04-P; CME 1.00; RN 1.00In this session, speakers from NMPA, Center for Drug Evaluation (CDE) and Center for Food and Drug Inspection (CFDI) will present and discuss the latest information on regulatory policy, drug review and approval, and international collaboration.Learning Objectives Recognize the latest...
See More →
Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
HS

Hui Shi

Director, Development Research Division, China Center for Food and Drug International Exchange, China
avatar for Ling Su

Ling Su

Research Fellow, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
QW

Qinghua Wang

Founder and CEO, Innogen Pharmaceuticals, China
Professor Qinghua Wang has dedicated over 30 years to translational research in metabolic diseases. He began his medical training in Shanghai, followed by graduate studies in Biochemistry in Antwerp. By 2000, he became an Assistant Professor at the University of Toronto’s Department... Read More →
avatar for Wei Zhang

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China
HZ

Huijuan Zhou

Exchange Division, China Center for Food and Drug International Exchange, China
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

4:15pm EDT

#558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115C
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-593-L04-P; CME 1.00; RN 1.00This session will showcase how Real-World Evidence (RWE) supports pediatric drug development in Asian countries, share US and EU perspectives, and highlight innovations in regulatory strategies, policies, and methodologies to enhance regulatory-grade pediatric RWE.Learning Objectives...
See More →
Speakers
avatar for Reiko Nakashima

Reiko Nakashima

Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Reiko Nakashima is a Deputy Review Director in the Office of New Drug III at the Pharmaceuticals and Medical Devices Agency (PMDA), where she is responsible for the review of new drugs for central nervous system (CNS) disorders.
SN

Shaoqing Ni

Attending Pharmacist , Director, Children's Hospital Zhejiang University School of Medicine, China
30+ years in pediatric pharmacy & clinical research. PhD, Chief Pharmacist, Doctoral Supervisor. Director of Clinical Trial Office, Children's Hospital, Zhejiang University; Head of Secretariat, China Pediatric Clinical Trial Network; Course Director, Zhejiang University graduate... Read More →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
YZ

Yongjing Zhang

Senior Director, Global Epidemiology, Johnson & Johnson, China
Dr. Zhang has been working on Real-World research in the pharmaceutical and medical device industry for over 18 years. He is dedicated to promoting global universal standards for electronic health databases in the Asia-Pacific region, practicing emerging theories and methods in epidemiological... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Data Management & Data Standards
  • Feature Topics Evidence Innovation
  • Tags Session

4:15pm EDT

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
117
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-595-L04-P; CME 1.00; RN 1.00In this session, we explore the transformative value of integrating AI and advanced analytics into Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality assurance, transforming Quality Assurance (QA) from a reactive oversight function to a value-generating...
See More →
Speakers
FC

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany
Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
JJ

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States
Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →
avatar for Michael Pelosi

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session

4:15pm EDT

#562: Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Diseases: Statistical Innovation and Novel Applications
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
116
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-596-L04-P; CME 1.00; RN 1.00Learn how the Real-World Evidence (RWE) can be utilized in studies of rare outcomes and diseases. Speakers from industry, academia, and regulators share insights on external controls, causal inference, and evidence synthesis to inform regulatory submissions.Learning Objectives Identify...
See More →
Speakers
avatar for Ruthie Davi

Ruthie Davi

Senior Vice President, Medidata, a Dassault Systèmes Company, United States
Ruthie Davi is Senior Vice President, Statistics and Regulatory Science Innovation at Medidata, and has a background in pharmaceutical clinical trials with more than 20 years working at the FDA, most recently as a Deputy Division Director in the Office of Biostatistics in CDER. At... Read More →
avatar for Jennifer Lyons

Jennifer Lyons

Research Scientist, Harvard Pilgrim Health Care Institute, United States
Jennifer Lyons is a Research Scientist in the Therapeutics and Infectious Disease Epidemiology group at the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. She works on the FDA-sponsored Sentinel Initiative for drug safety surveillance... Read More →
avatar for Van Tran

Van Tran

Mathematical Statistician, OTS, CDER, FDA, United States
Van Tran, PhD, is a Senior Mathematical Statistician at the U.S. Food and Drug Administration, where she provides statistical review of clinical trials and real-world evidence to support regulatory decisions on drug safety and efficacy. Her interests include evaluation of rare and... Read More →
avatar for Huan Wang

Huan Wang

Mathematical Statistician, CDER, FDA, United States
Dr. Huan Wang joined the FDA in 2021, where he focuses on statistical reviews for drug approval applications in non-malignant hematologic diseases. Prior to this role, he earned his Ph.D. in Biostatistics from the George Washington University, where he conducted research on developing... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session
 
Wednesday, June 17
 

8:00am EDT

#600: From Breakthrough to Life: Engineered T-Cells, Patients, and the Future of Biotech
Wednesday June 17, 2026 8:00am - 9:00am EDT
114
Component Type: SessionLevel: IntermediateFollowing a keynote presentation by Bruce Levine on the future of genetically engineered T-cells for human therapeutics, sit down with Bruce and Brad Watts for a fireside chat. Through scientific, policy, and patient lenses, the session will examine what it takes to translate high-risk science into sustainable therapies, and what that implies for...
See More →
Speakers
avatar for Bruce Levine

Bruce Levine

Barabara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine at the University of Pennsylvania, United States
avatar for Katie Truong

Katie Truong

SVP & Managing Director, DIA Americas and Global Head of Business Operations, DIA, United States
Katie Truong is the Senior Vice President & Managing Director of DIA Americas and the Global Head of Business Operations. In her role, Katie focuses on driving growth, optimizing operations, and enhancing business performance. With experience spanning various industries, including... Read More →
avatar for Bradley Watts

Bradley Watts

Patient/Industry Advocate and Vice President, Business Development Executive, Emily Whitehead Foundation and Conner Strong & Buckelew, United States
Brad Watts is a cancer survivor and CAR-T therapy recipient, Brad is an active advocate with The Emily Whitehead Foundation and Blood Cancer United, and is a member of Act for Hope, which is working to expand patient access by collaborating across the healthcare ecosystem. Drawing... Read More →
Wednesday June 17, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   00: Plenary, Session |   18: Lift-Series, Session

9:15am EDT

#601 IT: Faro Health Innovation Theater: Digital Protocols in Action - Enabling End-to-End Automation in Clinical Development
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 1
Component Type: SessionClinical trials still rely heavily on static Word documents to define and communicate protocol intent, creating manual handoffs, data inconsistencies, and delays across every downstream system. This session explores how digital, structured protocols serve as the foundation for end-to-end automation in clinical development, eliminating the translation layer between study...
See More →
Speakers
avatar for Vivian Dewoskin

Vivian Dewoskin

Chief Commercial Officer, Faro Health Inc., United States
Vivian is the Chief Commercial Officer at Faro, where she leads sales, marketing, and commercial strategy. She works closely with Faro’s customers to understand their needs and goals, and translate them into Faro’s product development roadmap. Prior to Faro, Vivian held multiple... Read More →
FH

Faro Health Inc.

United States
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

9:15am EDT

#602 IT: PhaseV Trials Innovation Theater: From Protocol to Submission - The Real-World Impact of AI in Clinical Operations
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 2
Component Type: SessionAs clinical trials grow increasingly complex, relying on historical correlations and rigid fixed designs is no longer viable. This session will discuss the practical application of AI across the clinical lifecycle, from identifying predictive early-derived endpoints to dynamically optimizing site selection and patient recruitment. We will share actionable success stories...
See More →
Speakers
P

PhaseV

United States
avatar for Raviv Pryluk

Raviv Pryluk

CEO, PhaseV, United States
Raviv is the co-founder & CEO of PhaseV, a technological company that developed a causal-ML-based platform for the design and execution of adaptive clinical trials. Raviv has over a decade of experience as a technological leader in the advanced technological defense industry, after... Read More →
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures
Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P; CME 1.25; RN 1.25Risk Minimization Measures (RMMs) target multiple healthcare stakeholders, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations, empirical examples, methodological advances, and insights from SmPC content analysis.Learning Objectives...
See More →
Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →
avatar for Helga Gardarsdottir

Helga Gardarsdottir

Professor RWD for decision making on medicines, Utrecht University, Netherlands
Helga Gardarsdottir is professor in use of RWD for decision making on medicines at Utrecht University (NL). Since January 2025, she has also been serving as a Seconded National Expert in the Data Analytics and Methods Taskforce (RWE Workstream) at the European Medicines Agency. Her... Read More →
avatar for Elaine Lippmann

Elaine Lippmann

Principal, Leavitt Partners, United States
Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work. Elaine most recently... Read More →
avatar for Daniele Sartori

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden
Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →
avatar for Gita Toyserkani

Gita Toyserkani

Regulatory Strategy Lead, Perspective Pharmacovigilance, United States
Dr. Gita Toyserkani, PharmD, MBA, is Regulatory Strategy Lead at Perspective Pharmacovigilance, where she advises life sciences companies on regulatory strategy across drug safety, risk management, and benefit–risk assessment. She brings more than 20 years of experience at the U.S... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Biostatistics
  • Tags Session

10:15am EDT

#604.1: Trial Navigator: Sponsors and Payors Discuss a Collaborative Non-Profit Recruitment Model to Better Connect Patients to Trials
Wednesday June 17, 2026 10:15am - 11:30am EDT
116
Component Type: ForumLevel: BasicDespite major investment, trial enrollment remains a system failure. Could a collaborative model align sponsors and payors – those who run trials & those with patient populations – via shared infrastructure and trusted human navigators? Help shape it.Learning Objectives Diagnose enrollment challenges as a system-level coordination failure; Outline shared values...
See More →
Speakers
PV

Percy Van Crocker

Founder and President, Agonist Health, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Tags Forum

10:15am EDT

#604: Counting the Cost: Translating Participant Burden into Fair Compensation
Wednesday June 17, 2026 10:15am - 11:30am EDT
108B
Component Type: WorkshopLevel: AdvancedCE: ACPE 1.25 Application UAN: 0286-0000-26-599-L04-P; CME 1.25; RN 1.25This interactive workshop moves beyond analysis to implementation—translating burden into cost and exploring fair compensation models to advance equity, access, and the participation experienceLearning Objectives Examine how participant burdens translate into measurable costs and affect...
See More →
Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
Donna Libretti Cooke, JD is Chief Impact Officer and Owner of ImpactSphere Clinical, LLC, advising pharma sponsors, CROs, and start-up vendors on participant payment strategy and clinical trial operations. She co-developed the Whole-Person Participant Support™ framework and led... Read More →
avatar for Lani Hashimoto

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States
Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States
T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →
BT

Bernadette Tosti

Partner, BGT Partners LLC, United States
Bernadette Tosti brings nearly 10 years of healthcare marketing, clinical trial recruitment and retention, and digital recruitment technology experience to her role at Quintiles. During her tenure at Quintiles, she has helped develop innovative technology solutions for recruitment... Read More →
SW

Shay Webb

Global Clinical Trials Operation, Emerging Talent Rotation, Merck & Co., Inc., United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Workshop

10:15am EDT

#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials
Wednesday June 17, 2026 10:15am - 11:30am EDT
108A
Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P; CME 1.25; RN 1.25In this session, sponsor companies present use cases on strategies and solutions deployed (e.g., digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.Learning Objectives Discuss case examples profiling solutions and practices that...
See More →
Speakers
avatar for Stephanie Christopher

Stephanie Christopher

Patient Engagement and Advocacy Lead, Pfizer, United States
Stephanie Christopher is a Patient Engagement and Advocacy Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies. In this role, she supports Pfizer’s Breast, Genitourinary... Read More →
avatar for Abigail Dirks

Abigail Dirks

Senior Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Senior Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative... Read More →
avatar for Katrina Mateo

Katrina Mateo

Associate Director, Development Innovation, Regeneron Pharmaceuticals, United States
Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session

10:15am EDT

#605: Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech
Wednesday June 17, 2026 10:15am - 11:30am EDT
109AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-602-L04-P; CME 1.25; RN 1.25Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models, examines FDA, EMA, and EU AI frameworks, and delivers strategies to ensure credible, compliant AI use in regulatory decision-making.Learning Objectives Differentiate between...
See More →
Speakers
GC

Graziella Collu

Vice President, Global Regulatory, AstraZeneca, Netherlands
avatar for Hussein Ezzeldin

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States
Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →
avatar for Donna Rivera

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
MR

Mark Rutter

Vice President, Regulatory Affairs, Formation Bio, United States
Mark Rutter is Vice President, Regulatory Affairs at Formation Bio, where he leads regulatory strategy across the development portfolio with a focus on innovative approaches to evidence generation. He brings extensive experience from leadership roles at Biogen, AbbVie, and Celgene... Read More →
MS

Megha Sinha

CEO, Kamet Consulting Group, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum

10:15am EDT

#607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies
Wednesday June 17, 2026 10:15am - 11:30am EDT
115AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-600-L04-P; CME 1.25; RN 1.25This session will explore how regulators are preparing to implement the New EU Pharmaceutical Legislation turning the digital by default ambition into practice, combining legislative reforms with digital and AI strategies.Learning Objectives Describe the digital by default ambition of...
See More →
Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Jeppe G. Manuel

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark
Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation... Read More →
DM

Derick Mitchell

Executive Director PFMD, The Synergist/Pfmd, Ireland
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Gabriel Westman

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden
GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

10:15am EDT

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis
Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P; CME 1.25; RN 1.25In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.Learning Objectives Describe the core principles of...
See More →
Speakers
FC

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany
Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
avatar for Karin Jonczak

Karin Jonczak

Clinical Capabilities Lead, Director, Bristol Myers Squibb, United States
IS

Ioannis Spyroglou

Associate Director, Data Science, MSD, United States
Ioannis Spyroglou, Ph.D., is Associate Director, Data Science in QA Analytics and Digital Innovation at Merck, and is based in Prague, Czech Republic. He co-leads Generative AI initiatives and develops solutions for quality assurance across different quality functions. Previously... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session

10:15am EDT

#601: Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets
Wednesday June 17, 2026 10:15am - 11:30am EDT
103A
Component Type: SessionLevel: AdvancedThis session takes participants inside the investor’s mind in today’s complex funding environment. Investors and financial leaders will discuss how they evaluate pipelines, platforms, and partnerships, where they look for differentiated deal flow, how valuation frameworks are changing, and what ultimately convinces them to lean in—or pass.Learning...
See More →
Speakers
avatar for Sahirzeeshan Ali

Sahirzeeshan Ali

Founder and General Partner, Modi Ventures, United States
Sahir Ali is the founder of Modi Ventures, a venture capital firm at the forefront of investing in the convergence of biology and technology. With a focus on scientific superintelligence and the engineering of life, he has backed breakthrough companies advancing AI-driven drug discovery... Read More →
MB

Mey Boukenna

Partner, Life Sciences & Healthcare Investments, PagsGroup, United States
Mey Boukenna, M.D., Ph.D., leads Biotechnology and Healthcare Investments at PagsGroup, Steve Pagliuca’s family office. She transitioned to investments after starting her career in medicine and research at the University of Bern, Switzerland. There, she conducted a few years of... Read More →
avatar for Raju Kucherlapati

Raju Kucherlapati

Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School, United States
Since 2001 Dr. Kucherlapati is the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School and was the first Scientific Director of the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG). He was a co-founder of several... Read More →
avatar for Jay Roberts

Jay Roberts

Partner, Ventac Partners, United States
Senior strategic executive in the biopharma industry for over 30 yrs. Serving as an Executive Advisor for Life365, a next generation AI platform connecting patients and providers. Also serves as a Partner with Ventac Partners, a global venture catalyst in life sciences and a Venture... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session |   18: Lift-Series, Session

10:15am EDT

#609: Decision Under Uncertainty
Wednesday June 17, 2026 10:15am - 11:30am EDT
203AB
Component Type: WorkshopLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-603-L04-P; CME 1.25; PDU 1.25 PMI 2166LODLKY; RN 1.25In this interactive workshop, participants will participate in an interactive, case-based racing simulation that places participants in a high-pressure “go/no-go” decision before the most important race of the season. This is one of Harvard's case studies most...
See More →
Speakers
avatar for Dave Bezick

Dave Bezick

Vice President, Medical Information, Propharma, United States
Dave brings over 17 years of Medical Information Contact Center Management and Operations experience. A licensed Registered Nurse, he began his career as a front-line Medical Information Specialist and has continually advanced into roles of increasing responsibility within the Medical... Read More →
avatar for Valerie Huh

Valerie Huh

Director, Global Innovation and Implementation, Propharma, United States
Valerie Huh has over 21 years of experience in the pharmaceutical, healthcare, and education sectors, with more than 11 years specializing in Contact Center and Medical Information Process Improvement. She holds a Pharm.D and an MBA and is passionate about leveraging advanced technology... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Workshop

10:15am EDT

#610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability
Wednesday June 17, 2026 10:15am - 11:30am EDT
105AB
Component Type: WorkshopLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-604-L04-P; CME 1.25; PDU 1.25 PMI 2166GIDLXI; RN 1.25Link common team dysfunction signals with a practical mapping method to uncover hidden beliefs and routines. Learn small, safe-to-learn experiments and simple indicators to build trust, enable healthy debate, and strengthen accountability.Learning Objectives Diagnose...
See More →
Speakers
avatar for John Dobbins

John Dobbins

Senior Manager, External Engagement, TransCelerate BioPharma Inc., United States
John Dobbins is an experienced change management practitioner and former educator. John is currently a senior manager of external engagement at TransCelerate BioPharma Inc., a collaborative biopharma consortium. In his day-to-day role, John supports TransCelerate's portfolio in its... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President Global Patient Safety, Argenx, United States
Jeremy Jokinen is the Vice President and Head of Global Patient Safety at argenx. He has more than 25 years of experience in the pharmaceutical industry, having held roles at Abbott Laboratories, Johnson & Johnson, AbbVie, and Bristol Myers Squibb. Jeremy has led numerous cross-industry... Read More →
avatar for Jessie Li

Jessie Li

Director of Project Delivery, Fifth Quadrant, United States
Jessie Li is the Director of Project Delivery at Fifth Quadrant, where she leads the design and execution of professional programs that foster collaboration, knowledge exchange, and innovative thinking among professionals and organizations. She brings extensive experience in clinical... Read More →
avatar for John Sun

John Sun

Program Lead, Portfolio, Strategy & Operations, CRM DU, Development, Novartis, United States
John is a Program Lead at Novartis, and had served as Global Analytics Project Manager and Global Program Team Director in different franchises. Before Novartis, he held positions at Whitehall-Robins, Kos Pharmaceuticals, Schering-Plough, and Sanofi-Aventis. John has actively volunteered... Read More →
avatar for Sarah Tremethick

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom
A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Workshop

10:15am EDT

#608: Can You Complete Your Submission in 10 Weeks?
Wednesday June 17, 2026 10:15am - 11:30am EDT
202AB
Component Type: WorkshopLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-605-L04-P; CME 1.25; PDU 1.25 PMI 2166B0UIY1 ; RN 1.25Drug development teams are being expected to deliver marketing applications in record time, despite increased complexity. This workshop is designed to give participants first-hand experience in such a submission.Learning Objectives Recognize key factors that must...
See More →
Speakers
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
SW

Sharon Wolfe-Schwartz

Executive Director, Regulatory Medical Writing, Harmony Biosciences Management, Inc., United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop |   08: RegPolicy-Strategy-GlobalCollaboration, Workshop |   04: MedAffairs-SciComm, Workshop

10:15am EDT

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-606-L04-P; CME 1.25; RN 1.25This workshop will delve into how the science and risk-based approaches outlined in ICH Q2(2) and Q14 connect to emerging revisions in ICH Q1(R1) and Q6(R1), highlighting their combined impact on product control strategies. Learning Objectives Recognize how ICH guideline revisions...
See More →
Speakers
PF

Philip Floyd

Global Vice President, Analytical R&D, AbbVie, United States
Phil currently serves as Global VP, Analytical R&D within Development Sciences at AbbVie and previously spent 22 years at GSK with last role as Head of US Analytical Development. Phil received his PhD in Analytical Chemistry at U. of Illinois under Jonathan Sweedler, at Beckman Institute... Read More →
TG

Timothy Graul

Senior Director, Pfizer, United States
Timothy W. Graul is a Senior Director in the CMC Advisory Office at Pfizer Inc. He received his B.S. in Chemistry at James Madison University and Ph.D. in Analytical Chemistry at Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the... Read More →
CL

Carolina Lopes Krahn

Health Regulation Specialist, ANVISA, Brazil
Pharmaceutical professional with a degree in Industrial Clinical Pharmacy and a Master’s degree in Pharmaceutical Sciences. Has been working as Health Regulation Expert for Anvisa for over 12 years working as a drug product registration reviewer, quality management professional... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
MR

Margaret Ruesch

Vice President, Pfizer, United States
Margaret Ruesch is the Vice President of Analytical Research & Development, Biotherapeutics Pharmaceutical Sciences organization. Analytical R&D is responsible for developing in-depth product and process understanding, testing clinical trial materials, authoring investigational and... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Workshop

10:15am EDT

#614: Indonesia Town Hall 2026
Wednesday June 17, 2026 10:15am - 11:30am EDT
112AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-656-L04-P; CME 1.25; RN 1.25Indonesia is advancing coordinated reforms across governance, regulation, and site readiness to achieve a four-months clinical trial start-up. This session highlights regulatory alignment, WHO recognition, ethics harmonization, and CRU transformation positioning Indonesia as a credible...
See More →
Speakers
avatar for Endang Hoyaranda

Endang Hoyaranda

President, Indonesian Association For the Study of Medicinals (IASMED), Indonesia
Endang is currently the President of the Indonesian Association for the Study of Medicinals, aside from holding her responsibilities as President of Prodia Utama which is the holding company of Prodia Group, a Group of 8 healthcare companies including the largest health laboratory... Read More →
avatar for Taruna Ikrar

Taruna Ikrar

Chairperson, Indonesia Food and Drug Authority, Indonesia
Prof. dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. Since August 2024, Prof. Ikrar brings exceptional expertise in pharmacology, cardiovascular science, and neuroscience to DIA's Annual Meeting. His remarkable journey spans education at Hasanuddin University, University of Indonesia, and... Read More →
avatar for Nina Dwi Putri

Nina Dwi Putri

Head of Sub-Unit Clinical Research Implementation, Clinical Research Unit Cipto Mangunkusumo Hospital, Indonesia
avatar for Budi Gunadi Sadikin

Budi Gunadi Sadikin

Minister, Ministry of Health, Indonesia
Mr. Sadikin was the Vice Minister I of State-owned Enterprises and tasked to establish market leading and globally competitive state-owned enterprises. From July 2020 until December, 22nd 2020, he lead the National Economic Recovery and Transformation Task Force amidst the COVID-19... Read More →
avatar for Indri Supriadi

Indri Supriadi

Head of BB Binomika (Parent Organization of INA-CRC), Indonesia Ministry of Health (MOH), Indonesia
Indri Rooslamiati Supriadi is Director of Indonesia’s National Center for Biomedical and Health Genomics and the Indonesia Clinical Research Center (INA-CRC) under the Ministry of Health. She leads national efforts in precision medicine and clinical research, streamlining regulations... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

10:15am EDT

#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact
Wednesday June 17, 2026 10:15am - 11:30am EDT
204AB
Component Type: ForumLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-607-L04-P; CME 1.25; RN 1.25The FDA Commissioner's National Priority Voucher (CNPV) program represents a novel regulatory mechanism designed to accelerate the development and review of drugs addressing critical public health priorities. This session provides a comprehensive analysisLearning Objectives Discuss the...
See More →
Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
EM

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey
avatar for Elizabeth Lange

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. From 2009 to 2021 he served as the Executive Director of CIRS. He is the Director of the DK Kim International (USC DRQS) and has been actively involved in promulgating... Read More →
MM

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States
KT

Kellie Taylor

VP, CMC Regulatory Affairs, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

10:15am EDT

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice
Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P; CME 1.25; RN 1.25Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs...
See More →
Speakers
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory policy and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Clinical Lead, Pfizer, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs. Her diverse experience in both large pharmaceutical... Read More →
HW

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Workshop |   02: ClinicalTrialOps-Innovation, Workshop

10:15am EDT

#613: FDA Rare Disease Town Hall
Wednesday June 17, 2026 10:15am - 11:30am EDT
201AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-609-L04-P; CME 1.25; RN 1.25Senior FDA leaders will discuss evolving regulatory trends in rare disease development, including accelerated approval, innovative trial designs, patient engagement, and real-world evidence, followed by open Q&A with attendees.Learning Objectives Identify current FDA regulatory trends...
See More →
Speakers
VK

Vijay Kumar

Acting Director OTP/CBER, FDA, United States
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine advises medical product companies and patient advocacy organizations on regulatory strategy for the development and approval of drugs and biologics, with a focus on rare diseases. He has helped secure FDA approvals, and often works in areas without well-defined regulatory... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

10:15am EDT

#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?
Wednesday June 17, 2026 10:15am - 11:30am EDT
117
Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-611-L04-P; CME 1.25; RN 1.25Share the gap of Decentralized Clinical Trial (DCT) regulation in the EU, US and Japan. The speakers also touch how to overcome them. The session is helpful for sponsor which plan the trials. Learning Objectives Explain DCT regulations in Japan, the US, and Europe and how to overcome...
See More →
Speakers
RE

Rasmus Enggaard

Therapy Area Head, CardioRenal/Liver/RareD, Novo Nordisk A/S, United States
Rasmus Enggaard is the Therapy Area Head for CardioRenal, Liver, and Rare Diseases in U.S. Clinical Development & Operations at Novo Nordisk, where he is responsible for execution of a broad and complex clinical trial portfolio. His work focuses on operational excellence, scalable... Read More →
RM

Ruri Matsumoto

Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   02: ClinicalTrialOps-Innovation, Session

11:30am EDT

#617 POS: Professional Poster Session III
Wednesday June 17, 2026 11:30am - 1:30pm EDT
Exchange
Component Type: Session

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
SA

Sharad Adekar

Senior Medical Chair, WCG, United States
Sharad Adekar, MD, PhD, CIP, is a Senior Medical Chair at WCG. He is a physician scientist with clinical experience in family practice and pediatrics and research experience in immunology, oncology, cardiovascular diseases, infectious diseases, and neurology. Dr. Adekar has experience... Read More →
avatar for Anna-Marika Bauer

Anna-Marika Bauer

Regulatory Specialist II, Critical Path Institute, United States
Anna-Marika Bauer is a regulatory specialist with the Regulatory Science program at the Critical Path Institute (C-Path). She received her undergraduate degree in Neuroscience from Franklin & Marshall College and her Master of Regulatory Affairs from the University of Pennsylvania... Read More →
avatar for Priyanka Bobbili

Priyanka Bobbili

Vice President, Analysis Group, Inc., United States
Dr. Bobbili specializes in the application of statistical methods for the causal analysis of complex longitudinal data. She has a wide range of experience in epidemiology and outcomes research, including studies on causal methods, drug adherence and comparative-effectiveness, particularly... Read More →
avatar for Rose Chang

Rose Chang

Vice President, Analysis Group, Inc., United States
Dr. Chang is an epidemiologist specializing in outcomes research and the application of advanced methods to generate real-world evidence (RWE) on unmet medical need, treatment patterns, and drug safety and effectiveness. She has experience across therapeutic areas using diverse health... Read More →
avatar for Susan Chong

Susan Chong

Senior Manager, Global Regulatory Policy and Intelligence, Amgen, United States
Susan Chong is Senior Manager, Global Regulatory Policy and Intelligence at Amgen, where she is responsible for the global regulatory commenting process on draft guidance documents, proposed rules and legislation, and more. Prior to this role, she was a Senior Associate Regulatory... Read More →
avatar for Grace Collins

Grace Collins

Manager, Regulatory & Data Insights, Friends of Cancer Research, United States
Grace Collins is Manager of Regulatory & Data Insights at Friends of Cancer Research. She leads the development of public data dashboards that track trends in oncology drug development and clinical trials. Her work focuses on analyzing regulatory and policy trends to inform science... Read More →
avatar for Lorraine Danks

Lorraine Danks

Senior Program Officer, Gates Foundation, South Africa
After spending 22 years in the pharmaceutical industry in regulatory affairs, QA and PV roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, Lorraine Danks joined the South African medicines regulator, SAHPRA, in June 2020 to head up the organization’s... Read More →
avatar for Mei Sheng Duh

Mei Sheng Duh

Managing Principal, Analysis Group, Inc., United States
Dr. Mei Sheng Duh, M.P.H., Sc.D., is a Managing Principal and Chief Epidemiologist at Analysis Group. She specializes in decision-grade real-world evidence (RWE) to support product registration, post-approval safety and effectiveness studies, and health technology assessments of pharmaceuticals... Read More →
avatar for Motoki Fujii

Motoki Fujii

Exective Professional, EPS Group, Japan
[Expertise] Medical device regulatory consultant Support for the creation of medical device regulatory-related materials Strategy planning and support for face-to-face advice provided by PMDA Correspondence with overseas clients [Career] After joining EPS in 2008, engaged in consulting... Read More →
avatar for BI-KAI HSU

BI-KAI HSU

Senior Project Manager, Center For Drug Evaluation, Taiwan, Taiwan
I received my Master’s degree in Pharmacology from National Yang-Ming University, Taiwan. I began my career at the Taiwan Food and Drug Administration (TFDA) through alternative military service, where I gained foundational experience in regulatory review. I later worked in the... Read More →
KK

Kaili Kulbacki

Clinical Research Professional, Solaire Solutions, United States
HK

Houshen Kuo

reviewer, Taiwan Food and Drug Administration, Taiwan
avatar for Eui-Kyung Lee

Eui-Kyung Lee

Professor, School of Pharmacy, SKKU (sungkyunkwan University), Korea, Republic of
Dr. Eui-Kyung Lee is Professor of Pharmaceutical Policy and Outcomes Research at Sungkyunkwan University, South Korea. She served as Minister of the Ministry of Food and Drug Safety (2019–2020), leading emergency authorizations for COVID-19 diagnostics and fast-track approvals of... Read More →
avatar for Carmen Lin

Carmen Lin

Global Regulatory Affairs Content Strategist Specialist, Roche, Canada
Carmen is a Global Regulatory Content Specialist focusing on regulatory strategy at Roche. A graduate of the University of Toronto’s PharmD program (2023), she maintains her clinical expertise as a registered pharmacist. She has extensive experience in labeling, program management... Read More →
avatar for ChiaPing Liu

ChiaPing Liu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Ms. Liu has received her bachelor degree in pharmacy from Taipei Medical University and later acquired her pharmacist certificate. She has received her master degree in Law from National Cheng Chi University. She has been serving in Taiwan Food and Drug Administration (TFDA) these... Read More →
avatar for Arun Mathew

Arun Mathew

Director, AbbVie, United States
Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.
JM

Julia Mauro

Project Specialist, DIA, United States
avatar for Yuki Miyatake

Yuki Miyatake

Sr Group Manager, Eli Lilly and Company, Japan
Yuki Miyatake is a Senior Group Manager of Policy and Excellence at Eli Lilly Japan KK, specializing in regulatory policy strategy and intelligence. Driven by his personal experiences as a former patient, Yuki is passionate about fostering an innovative regulatory environment that... Read More →
avatar for Satchell Mede Pacheco

Satchell Mede Pacheco

Medical Affairs Strategy Fellow, Rutgers Univerity, United States
Satchell Mede Pacheco, PharmD is a Medical Affairs Strategy professional focused on roles at the intersection of scientific rigor, commercial insight, and patient impact. She is motivated by shaping strategies that expand access to innovation, strengthen evidence generation, and elevate... Read More →
VP

Vihanga Pahalawatta

Director Regulatory Affairs, AbbVie, United States
Vihanga Pahalawatta has over 10 years of industry experience related to In Vitro Diagnostic (IVD) products and Companion Diagnostics (CDx) in Research and Development and Regulatory Affairs. In her current role at AbbVie, Vihanga leads the CDx device regulatory group, guiding teams... Read More →
JP

Jami Peters

Associate Director, Gilead Sciences, United States
I’m a pharmacoepidemiologist with 13 years of experience in the biotechnology industry. My background includes five years in drug safety operations, which continues to strongly inform my current work. I bring hands-on experience with real-world evidence to support pharmacovigilance... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
avatar for Patrick Rodriguez

Patrick Rodriguez

Policy Analyst, Duke-Margolis Institute For Health Policy, United States
Patrick Rodriguez is a Policy Analyst at the Duke-Margolis Institute for Health Policy on the Biomedical Innovation team. He primarily supports projects under the FDA and Real-World Evidence portfolios. He holds a MA in Bioethics and Science Policy with concentrations in both technology... Read More →
GR

Gargi Roy

Regulatory Affairs Associate, Servier Canada, Canada
I am a Regulatory Affairs Professional with a Bachelor's degree in Pharmacy and a Masters in drug Development specializing in Regulatory Affairs. With over 4 years of experience in Regulatory affairs and previous experience in Quality Assurance, I have expertise in pharmaceutical... Read More →
HS

Harsh Shah

CoFounder and CEO, Clinplex, United States
Harsh Shah is Co-Founder and CEO of Clinplex, an AI regulatory intelligence company focused on continuous compliance assessment for pharmaceutical, biotech, and medical device organizations. He brings 16+ years of pharmaceutical Quality Assurance and Regulatory Affairs experience... Read More →
JS

Jennifer Shelton

Solution Executive, Actalent, United States
Clinical Operations and Solution Executive at Actalent with 16+ years of experience leading global Phase I–IV clinical trials across Oncology, CNS, Rare Disease, vaccines, Infectious and Dermatologic Diseases, CAR-T, Medical Device, and preventive and therapeutic programs. Partners... Read More →
avatar for Molly Shields

Molly Shields

Policy Analyst, Assistant, Duke-Margolis Institute For Health Policy, United States
Molly Shields is a Policy Analyst, Assistant on the Biomedical Innovation team at Duke-Margolis where she supports the Institute's work on clinical trials, real-world evidence, and U.S. Food and Drug Administration cooperative agreements. During her undergraduate career, she conducted... Read More →
avatar for Ayoub Suliman

Ayoub Suliman

Regulatory Health Project Manager, FDA, United States
I am a Regulatory Health Project Manager with FDA/CDER's Office of Medical Policy (OMP). In my current role, I support policy development activities for OMP's innovation portfolio including Digital Health Technologies, Real-World Evidence, and Artificial Intelligence programs. I also... Read More →
avatar for Amisha Tayal

Amisha Tayal

Regulatory Labeling & Advertising/Promotion Fellow, Pfizer, United States
Amisha Tayal, PharmD, MBA is a Regulatory Labeling and Advertising & Promotion Fellow at Pfizer through the Howard University postdoctoral fellowship program. In her role, she supports cross-functional stakeholders on U.S. labeling strategy, regulatory submissions, and advertising... Read More →
KB

Khim Boon Tee

Senior Principal Assistant Director, National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Malaysia
Dr. Tee Khim Boon is a regulatory expert specializing in GCP and BE inspections. She contributes to Malaysia’s NPRA, ensuring data integrity across borders. Between 2014 and 2023, she led oversight missions in India, Taiwan, Thailand, Indonesia, and Romania . Over the past three... Read More →
avatar for Katherine Toran

Katherine Toran

Economist, FDA, United States
Katherine Toran serves as Economist at the Food and Drug Administration, specializing in prescription drugs. Katherine holds a PhD in Economics from University of Kentucky.
avatar for Apurva Uniyal

Apurva Uniyal

Regulatory Innovation Research Scientist, The DK Kim International Center, Department of Regulatory and Quality Sciences,, United States
Apurva Uniyal, MA, MS, is a Regulatory Innovation Research Scientist at the D.K. Kim International Center for Regulatory Science. With an MS from USC and over 20 years of experience in clinical and regulatory research, she brings both academic and practical expertise to her role... Read More →
JW

Jun-Fon Wang

Senior Clinical Reviewer, The Center For Drug Evaluation (CDE), Taiwan, Taiwan
Multidisciplinary pharmaceutical expert with a solid foundation in clinical pharmacy and extensive experience in regulatory strategy, clinical review, and global drug development. Specialized in benefit–risk assessment of NDA/BLA and IND submissions, post-approval efficacy/safety... Read More →
avatar for Mia Williams

Mia Williams

Policy Analyst, Duke-Margolis Institute For Health Policy, United States
avatar for Meng-Hsiu Wu

Meng-Hsiu Wu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan
Wednesday June 17, 2026 11:30am - 1:30pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session

11:40am EDT

#618 CH: Regulatory Excellence as an Enabler for Sustainable Manufacturing in Africa
Wednesday June 17, 2026 11:40am - 12:10pm EDT
Content Hub
Component Type: WorkshopLevel: IntermediateThis session will explore how regulatory system strengthening and harmonization can act as a catalyst for regional pharmaceutical manufacturing in Africa, ensuring access to quality-assured medicines and building a resilient health ecosystem.Learning Objectives 1. Discuss the role of regional regulatory harmonization initiatives in reducing duplication,...
See More →
Wednesday June 17, 2026 11:40am - 12:10pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

12:20pm EDT

#619 CH: The End of the Static Protocol: How Digital Blueprints Will Orchestrate the Next Generation of Clinical Trials
Wednesday June 17, 2026 12:20pm - 12:50pm EDT
Content Hub
Component Type: WorkshopLevel: IntermediateWhat if protocols weren’t documents - but executable trial blueprints? Learn how protocol digitization into structured USDM content, combined with clinical operational data, enables orchestration across systems to streamline and improve trials. Learning Objectives Identify how digital protocols and structured USDM models improve clinical operations and...
See More →
Wednesday June 17, 2026 12:20pm - 12:50pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

12:30pm EDT

#620 RT: Roundtable Discussion: Can You Complete Your Submission in 10 weeks?
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone B
Component Type: Session
Level: Intermediate

Join the Medical Writing Community for a follow up round table discussion tied to session: Can You Complete Your Submission in 10 weeks? (Wednesday, June 17 | 12:30pm - 1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Steve Sibley, MS
Sharon Wolfe-Schwartz, MS

Speakers
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

12:30pm EDT

#621 RT: Roundtable Discussion: International Regulatory Cooperation with the African Medicines Agency
Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone A
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: International Regulatory Cooperation with the African Medicines Agency Wednesday, June 17 | 12:30pm -1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Chaitanya Koduri, DDS, MHS

Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:45pm EDT

#622: Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-612-L04-P; CME 1.00; RN 1.00This forum will explore how pharmacovigilance strengthens vaccine confidence and reduces hesitancy through safety monitoring, transparent communication, and healthcare professional training, with lessons from Brazil and international perspectives.Learning Objectives Describe how...
See More →
Speakers
avatar for Vera Gattás

Vera Gattás

QPPV, Instituto Butantan , Brazil
Graduated in Nursing from Escola Paulista de Medicina - Depto. Nursing (1979); Master in Public Health from the Faculty of Public Health of the University of São Paulo - USP (1996) and PhD in Tropical Diseases and International Health from the Institute of Tropical Medicine at USP... Read More →
avatar for Patricia Mouta

Patricia Mouta

Pharmacovigilance specialist, Biomanguinhos/Fiocruz, Brazil
Dr. Patrícia Mouta is a Medical Doctor and Patient Safety specialist with extensive experience in pharmacovigilance and vaccine safety. Since 2011, she has worked as a Safety Physician at Bio-Manguinhos/Fiocruz, a leading public manufacturer of vaccines and biopharmaceuticals in... Read More →
avatar for Mayra Oliveira

Mayra Oliveira

pharmacovigilance manager, Instituto Butantan, Brazil
Since graduating as a nurse in 2007, I have built a solid career in immunization, working across different areas including vaccination clinics, clinical research coordination, and clinical operations management. Over the years, I progressed into vaccine safety and currently serve... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

1:45pm EDT

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P; CME 1.00; RN 1.00This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends, benchmarking protocol data collection practices, and offering new, practical strategies to simplify protocol designs and reduce participant and site burden.Learning Objectives Analyze new...
See More →
Speakers
JC

Jackie Cole

Director, Design and Innovation, Clinical Operations, Gilead Sciences, United States
Jackie Cole is a clinical development innovator with more than two decades of experience across clinical operations and site engagement. At Gilead, she serves as Director of Design & Innovation, driving enterprise-wide innovation strategies that reshape how trials are designed and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session |   04: MedAffairs-SciComm, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations,Data Management & Data Standards
  • Tags Session

1:45pm EDT

#623: Designing the Future: Emulation of Clinical Trials Using Real-World Data
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P; CME 1.00; RN 1.00Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges. Learning Objectives Explain how trial emulation using real-world data...
See More →
Speakers
JS

Jingchuan Serena Guo

Associate Professor, Purdue University, United States
avatar for Donna Rivera

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
avatar for Leo Russo

Leo Russo

Advisor, Get Real Institute, United States
I bridge the gap between clinical trials and real-world outcomes, ensuring breakthrough therapies deliver on their promise to patients. Leading teams across pharmaceutical development for 25+ years, I've pioneered trial emulation, AI analytics, and pragmatic designs that generate... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

1:45pm EDT

#625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
109AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-618-L04-P; CME 1.00; RN 1.00This session presents AI consortium working group assessments on regulatory frameworks, use case classification, and validation approaches. Participants engage with practical tools while demystifying real AI deployments and regulatory requirements.Learning Objectives Apply standardized...
See More →
Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
ML

Michael Lingzhi Li

Assistant Professor, Harvard Business School, United States
Michael Lingzhi Li is an Assistant Professor in the Technology and Operations Management unit at Harvard Business School. His research focuses on the end-to-end development of decision algorithms based on machine learning, causal inference and operations research. He examines the... Read More →
avatar for Christina Mack

Christina Mack

CSO RWE and SVP AAIS, IQVIA, United States
Christina Mack, Ph.D. is senior vice president of Applied AI Science within the AI and Technology Solutions (ATS) business, where she is responsible for driving scientific and technical innovation across the organization that has direct impact on patient health. Dr. Mack also leads... Read More →
avatar for Sridevi Nagarajan

Sridevi Nagarajan

DIA Communities Chair for AI in Healthcare, Ayusarogya, United Kingdom
An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →
avatar for Carrie Nielson

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States
Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →
LR

Leon Rozenblit

Executive Director, Q.E.D. Institute, United States
Leon Rozenblit is a nationally recognized thought leader at the intersection of clinical research informatics and AI governance. As Co-Founder and Executive Committee member of the DCI Network at Beth Israel Deaconess Medical Center, Harvard Medical School, he has co-organized two... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum

1:45pm EDT

#626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
107AB
Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-616-L04-P; CME 1.00; RN 1.00Comprehensive benchmarking of four major LLMs across 100 FDA approval packages identifies optimal models for regulatory tasks. Study provides critical insights on accuracy, limitations, and implementation strategies for regulatory AI adoption.Learning Objectives Identify which LLM models...
See More →
Speakers
avatar for skay8

skay8

VP of Pharmaceutical Strategy, Basil Systems, United States
Sam Kay is Vice President of Pharma at Basil Systems, where he leads AI-powered regulatory intelligence solutions for global pharmaceutical companies. A recognized authority in the field, Sam co-authored Chapter 6 of Regulatory Intelligence Reimagined (RAPS) and teaches Regulatory... Read More →
CK

Cameron Kieffer

Director, Global Regulatory Intelligence and Policy Research, Takeda, United States
avatar for Jeff MacDonald

Jeff MacDonald

Associate Director, Global Regulatory Policy and Intelligence, BeOne Medicines, United States
AM

Aleksandr Merenkov

Associate Director, Global Regulatory Intelligence, Genmab US, Inc., United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

1:45pm EDT

#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB
Component Type: ForumLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-615-L04-P; CME 1.00; RN 1.00We’ll review the history, laws, and policies of the current data sharing environment. We’ll discuss ethical considerations for why the typical approach to consent and deidentification of data hinder trust and innovation. We’ll give a case study of paLearning Objectives Describe the...
See More →
Speakers
avatar for Sarah Chamberlin

Sarah Chamberlin

Founder and Chief Program Officer, flok, United States
Sarah Chamberlin is Founder & Chief Program Officer of flok Health, a nonprofit advancing care and research for inherited metabolic disorders. She is a leader in patient-directed research and participatory data models, building community-powered data infrastructure that centers patient... Read More →
avatar for Karla Childers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States
Karla Childers is Vice President, Bioethics, Policy & Partnerships in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →
avatar for Mary Gray

Mary Gray

Senior Principal Researcher, Microsoft Research, United States
Mary L. Gray is a Senior Principal Researcher at Microsoft Research and a leading scholar of the social and ethical dimensions of data-driven AI systems. Trained as an anthropologist, her research examines how digital infrastructures shape labor, identity, and human rights. She leads... Read More →
AL

Aaron Leibtag

CEO, Pentavere, Canada
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   02: ClinicalTrialOps-Innovation, Forum

1:45pm EDT

#628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
105AB
Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-619-L04-P; CME 1.00; RN 1.00This session provides a framework and tools to adopt a business mindset, helping regulatory writing leaders and teams shift from document/submission execution to strategic influence. Learning Objectives Discuss building a business mindset; Identify practical methods to incorporate business...
See More →
Speakers
avatar for Tatyana Wanderer

Tatyana Wanderer

Executive Director, Head of Medical Writing and CTD, Moderna, United States
With over 10 years of experience in the pharmaceutical industry, Dr. Wanderer brings innovative thinking and lean process-focused approach. As the Head of Medical Writing at Syros Pharmaceuticals, Tatyana leverages experience in both biotech/pharma side and the vendor side. On the... Read More →
avatar for Tatyana Wanderer

Tatyana Wanderer

Executive Director, Head of Medical Writing and CTTD, Moderna, United States
Tatyana Wanderer, PhD, is Head of Medical Writing and Clinical Trial Transparency & Disclosure at Moderna, where she leads global teams focused on delivering high-quality clinical documentation and advancing transparency. With nearly two decades of experience across regulatory writing... Read More →
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
avatar for Angela Winnier

Angela Winnier

Executive Director of Medical Writing, Pfizer, United States
Angela Winnier joined Pfizer in 2018 and is Executive Director of Medical Writing and the therapeutic area lead for internal medicine and inflammation/immunology. In addition to her pipeline support, Angela serves as technology lead for medical writing, providing strategic and operational... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

1:45pm EDT

#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-620-L04-P; CME 1.00; RN 1.00Examine evolving extractables and leachables (E&L) regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks. Learning Objectives Evaluate current global...
See More →
Speakers
avatar for Karthik Balasubramanian

Karthik Balasubramanian

Dir Project/Program Management, External Manufacturing, Teva Pharmaceuticals, United States
Dr. Karthik Balasubramanian, Ph.D is Director, Program and Project Management at Teva Pharmaceuticals. He has over 20 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in... Read More →
JG

Ji Guo

Chemist, OPQ, CDER, FDA, United States
Dr. Ji Guo is a chemist in the Office of Policy for Pharmaceutical Quality (OPPQ) within the Office of Pharmaceutical Quality (OPQ) at the FDA's Center for Drug Evaluation and Research (CDER). Her work encompasses scientific review of drug quality issues, policy analysis, and collaboration... Read More →
avatar for Chaitanya Koduri

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

1:45pm EDT

#629: Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
103A
Component Type: SessionLevel: IntermediateThis candid panel looks inside notable biotech breakthroughs to explore what “success” really takes beyond the headlines. Through case studies from leading venture groups and founders, speakers will unpack key decisions, near misses, pivots, and partnership strategies, translating them into practical lessons for emerging companies and their...
See More →
Speakers
avatar for Gabriela Apiou

Gabriela Apiou

Investigator, Assitant Professor (M), Massachusetts General Hospital, United States
Gabriela Apiou, PhD, is an Assistant Professor of Dermatology at Massachusetts General Hospital (MGH) and Harvard Medical School, the inaugural Endowed MGH Research Institute Chair in Translational Sciences, and Director of the MGH Wellman Center for Photomedicine’s Translational... Read More →
AC

Abbie Celniker

Partner, Third Rock Ventures, United States
avatar for Robert Tepper

Robert Tepper

Co-founder and Partner, Third Rock Ventures, United States
Bob Tepper is a co-founder and Partner of Third Rock Ventures and a distinguished physician-scientist with more than 30 years of experience building and operating leading research and development organizations in the biotech industry. Bob focuses on the formation, development, and... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   18: Lift-Series, Session

1:45pm EDT

#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
202AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-621-L04-P; CME 1.00; PDU 1.00 PMI 21663K6JS3; RN 1.00This workshop helps break through habitual thinking and guide teams toward inventive, high-impact strategies. Participants will engage in activities to encourage team engagement, uncover hidden constraints, and practice leading with confidence.Learning...
See More →
Speakers
AA

Amanda Adamek

Organon, United States
avatar for Nathan Kreischer

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc., United States
Nathan is a Director within Global Project & Alliance Management at Merck. He has almost 20 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →
avatar for Larissa Wilsie

Larissa Wilsie

Sr. Director, PPM Business Development, GlaxoSmithKline, United States
A cell biologist by training, Larissa moved into project management in 2013 and has worked across therapeutic areas, supporting programs from early stage development through post-approval activities. She has been able to apply PM skills in a variety of settings beyond drug development... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop

1:45pm EDT

#632: Program Manager: Jack of All Trades, Master of None?
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
203AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-622-L04-P; CME 1.00; PDU 1.00 PMI 21668R8O1J ; RN 1.00The program manager role can be found within many functional areas, including discovery research, manufacturing, regulatory, and, the ultimate jack of all trades, the global program manager. Learning Objectives Recognize the diversity of PM role with respect to...
See More →
Speakers
avatar for Simina Grigoriu

Simina Grigoriu

Director, R&D Operations, Accent Therapuetics, United States
Simina is an early-stage clinical program manager who draws on over a decade of experience spanning the continuum from drug discovery to early clinical development. Trained in structural biology and protein sciences, she led Protein & Structural Sciences teams before moving into program... Read More →
avatar for Rosa Tarng

Rosa Tarng

Early Development Leader, GSK, United States
Rosa Tarng is a drug development professional with over 20 years of industry experience. Rosa is currently an Early Development Leader at GSK. Prior experience includes leading Research and Translational program management teams as well as managing drug development programs and portfolios... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session

1:45pm EDT

#633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118C
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-672-L04-P; CME 1.00; RN 1.00EU’s Reflection Paper introduces a tailored clinical approach for biosimilars, driving an optimised and efficient development programme by reducing unnecessary studies, as regulators and industry discuss opportunities for patient access and global harmonization.Learning Objectives...
See More →
Speakers
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

1:45pm EDT

#635: MHRA Town Hall
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
119AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-626-L04-P; CME 1.00; RN 1.00In this session, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.Learning Objectives Describe...
See More →
Speakers
avatar for Julian Beach

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

1:45pm EDT

#636: The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
201AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-625-L04-P; CME 1.00; RN 1.00This panel will explore how patient advocacy can shape regulatory strategy, trial design, and access planning for autoimmune cell and gene therapies as they move toward future approvals.Learning Objectives Identify how patient advocacy can shape regulatory strategy and access for future...
See More →
Speakers
JB

Joy Buie

Vice President of Research, Lupus Foundation of America, United States
Dr. Joy Buie is a nurse-scientist and leader advancing patient-centered innovation in autoimmune disease, particularly lupus. She leads strategic research initiatives that integrate real-world and patient experience data into clinical development, regulatory decision-making, and therapeutic... Read More →
PE

Paula Eichenbrenner

Executive Director, The Myositis Association, United States
BK

Brian Kennedy

Executive Director, Global Alliance for Patient Access, United States
VK

Vijay Kumar

Acting Director OTP/CBER, FDA, United States
avatar for Samantha Roberts

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

1:45pm EDT

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P; CME 1.00; RN 1.00Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs, Medical Affairs, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.Learning Objectives Examine the...
See More →
Speakers
EL

Emma Lee

Executive Director and Head, US Medical Affairs Patient Access and Quality, Gilead Sciences, United States
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
SS

Sean Sullivan

Prof. of Pharmacy, Public Hlth, University of Washington, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   04: MedAffairs-SciComm, Session

1:45pm EDT

#637: Destigmatizing 483 Observations
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-627-L04-P; CME 1.00; RN 1.00Hear from regulators and industry on the challenges and opportunities in supporting sponsors through 483 observations. Panelists will discuss their impact on monitoring strategies and the role that centralized monitoring plays in mitigating violations.Learning Objectives Discuss the...
See More →
Speakers
avatar for Erin Brown

Erin Brown

Director, Industry Intelligence and Messaging, Association of Clinical Research Organizations (ACRO), United States
Erin Brown is the Director of Industry Intelligence and Messaging for the Association of Clinical Research Organizations (ACRO), where she leads survey development, collection, and analysis related to risk-based quality management (RBQM) adoption, FDA regulatory trends, and other... Read More →
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA, United States
David Burrow is the Director of the Office of Scientific Investigations (OSI) within the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). He leads CDER's Bioresearch Monitoring (BIMO) program, overseeing clinical... Read More →
avatar for Cris McDavid

Cris McDavid

Senior Director, GCDO, Parexel International, United States
Cris McDavid is a seasoned clinical research leader with over 20 years of global clinical trial delivery experience. Cris leads Parexel Risk-Based Quality Management (RBQM) operations and Integrated Data Delivery (IDD), driving strategic process and technology implementation across... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States
Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →
avatar for Tracy Vanderslice

Tracy Vanderslice

Vice President, Clinical Operations, Gilead Sciences, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

1:45pm EDT

#638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-628-L04-P; CME 1.00; RN 1.00Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed. Learning...
See More →
Speakers
avatar for Patricia Furlong

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States
Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →
avatar for Rohini Hernandez

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States
Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

3:00pm EDT

#629.2 RT: Roundtable Discussion: Insights Regarding Implementation of the ASAP Process
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Join the Clinical Safety and Pharmacovigilance Community for a follow up round table discussion tied to session: Insights Regarding Implementation of the ASAP Process (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PHD

Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

3:00pm EDT

Roundtable Discussion: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD
Component Type: SessionLevel: IntermediateJoin the AI in Healthcare Community for a follow up round table discussion tied to session: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Sridevi...
See More →
Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

4:00pm EDT

#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-629-L04-P; CME 1.00; RN 1.00This session will share insights into signal detection approaches across different product types, exploring how regulators, industry, and academia are leveraging new technologies and data sources to address current challenges and advance pharmacovigilance practices.Learning Objectives...
See More →
Speakers
avatar for Judith Maro

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States
Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →
avatar for Monica Munoz

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
avatar for Jeffery Painter

Jeffery Painter

Senior Director, Quantitative Leader for Safety Innovation & Analytics, GlaxoSmithKline, United States
Jeffery Painter is the Quantitative Leader for Safety Innovation and Analytics at GSK, advancing pharmacovigilance through Bayesian methods, semantic similarity, and ontology-driven analytics. He is the author of PVLens, a drug safety reference database derived from regulatory labeling... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Tags Session

4:00pm EDT

#645: Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108B
Component Type: Session
CE: ACPE 1.00 Application UAN: 0286-0000-26-631-L04-P; CME 1.00; RN 1.00



Speaker

Panelist
Lani Hashimoto

Panelist
Loriana Hernandez-Aldama

Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas
Robina Weermeijer

Panelist
Mitch Herndon, MPH


Speakers
avatar for Lani Hashimoto

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States
Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →
avatar for Loriana Hernandez-Aldama

Loriana Hernandez-Aldama

Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup Media, United States
Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →
avatar for Mitch Herndon

Mitch Herndon

Head, Patient Experience & Recruitment, UCB Biosciences, United States
Mitch Herndon leads a global team at UCB in meeting study enrollment and improving the experience of clinical study participants. Mitch has 29 years of experience in partnering with patients including at a pediatric clinic, patient organization, CRO and pharma. He has served in a... Read More →
RW

Robina Weermeijer

Boehringer Ingelheim, Netherlands
Robina Weermeijer is a Trial Patient & Site Engagement Lead within Global Clinical Development Operations, based in Amsterdam. With a strong focus on enhancing patient and site experiences in clinical trials, she works to elevate patient and site voices. In addition, she plays a key... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

4:00pm EDT

#644: 50,000 Participants, Two Countries, One DCT: Oversight That Worked
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-630-L04-P; CME 1.00; RN 1.0050,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.Learning Objectives Differentiate traditional monitoring from...
See More →
Speakers
LC

Lisa Collins

Founder - Head Clinical Operations, Innomas Clinical Research (Africa), Nigeria
Lisa Ursella Collins is Co-Founder and CEO of Innomas Clinical Research and a global clinical operations and program leader. She works at the intersection of clinical execution, quality, and operational risk—translating development strategy into disciplined delivery. Through Innomas... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   09: RD-Quality-Compliance, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

4:00pm EDT

#646: Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
109AB
Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-633-L04-P; CME 1.00; RN 1.00Siloed data stifles advancements in AI-powered drug discovery. Federated computing (FC) provides a secure, privacy-preserving, decentralized approach that enables AI-model sharing, fine-tuning and inference - moving AI demos to real-world applications.Learning Objectives Define Federated...
See More →
Speakers
avatar for Ittai Dayan

Ittai Dayan

CEO, Rhino Federated Computing, United States
Dr. Ittai Dayan is the Co-Founder and CEO of Rhino Federated Computing, a company transforming the way data is used for creating and deploying Artificial Intelligence solutions in regulated industries. A pioneer of bringing privacy preservation technologies into regulated industries... Read More →
JG

Jonathan Gilbert

Senior Director, Ecosystem Growth and Contributor Partnerships, Eli Lilly and Company, United States
NH

Nadia Harhen

General Manager, AI Simulation, SandboxAQ, United States
KT

Kyle Tretina

Product Marketing Lead, NVIDIA, United States
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Forum

4:00pm EDT

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-632-L04-P; CME 1.00; RN 1.00Visionary leaders will debate three options for the ideal AI-transformed future state of the clinical trials enterprise. Attendees will appraise these big ideas, consider market implications, and reflect on their roles in getting us there. Learning Objectives Evaluate three “big goals"...
See More →
Speakers
avatar for Tala Fakhouri

Tala Fakhouri

Vice President, AI & Digital Policy, Real-World Research, Parexel International, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Morgan Hanger

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →
HW

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States
avatar for Gabriel Westman

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden
GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Clinical Development & Operations
  • Feature Topics Artificial Intelligence
  • Tags Forum

4:00pm EDT

#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-634-L04-P; CME 1.00; RN 1.00Discover how Medical Affairs drives strategic value across the drug lifecycle through scientific leadership, data-driven insights, and digital fluency to improve patient outcomes.Learning Objectives Discuss Medical Affairs’ evolving role in driving scientific credibility and impact;...
See More →
Speakers
AC

Alexander Condoleon

Chief Medical Affairs Officer, Medical Engagements & Impact, Pfizer, United States
avatar for Donna Holder

Donna Holder

Principal, HDMA Advisory, United States
Donna Holder has over 30+ yrs experience in the pharma. She now serves as an advisor to Medical Affairs organizations within the pharmaceutical industry. She was recently the Executive Director & Head of Digital Strategy and Innovation in Global Oncology Medical Affairs at Daiichi... Read More →
avatar for Sarah Jarvis

Sarah Jarvis

Global Medical & Evidence Lead, ZS Associates, United States
Sarah Jarvis leads our Global Medical & Evidence consulting space at ZS. Based now in San Francisco, California, Sarah has worked in the lifesciences industry for over 25 years and has focused exclusively on working with medical affairs clients for the past 20+ years at ZS. ZS has... Read More →
RP

Ranjini Prithviraj

Director, Global Medical Affairs, Publication Management, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session

4:00pm EDT

#649: Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
119AB
Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-635-L04-P; CME 1.00; RN 1.00Multi-stakeholder research reveals why long-term follow-up fails in gene therapy despite new FDA requirements. Speakers across patient advocacy, clinical research, and medical ethics examine the social conception of long-term follow-up, its challenges, and practical solutions for sustainable...
See More →
Speakers
avatar for Alen Agaronov

Alen Agaronov

Independent, United States
Alen Agaronov ScD is a social scientist, bioethicist, and business ethicist focusing on new medical technologies and patient advocacy and engagement. He holds a doctoral degree in Social & Behavioral Sciences from the Harvard T.H. Chan School of Public Health and completed postdoctoral... Read More →
avatar for Dennis Akkaya

Dennis Akkaya

Corporate Development, My Tomorrows, United States
avatar for Carolyn Chapman

Carolyn Chapman

Independent Consultant, Freelance, United States
Dr. Chapman is currently an Independent Consultant at the intersections of pharmaceutical development, genetic technologies, policy, ethics, and strategy. Previously, she directed the CGT project at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital (BWH) and... Read More →
avatar for Patricia Furlong

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States
Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Forum

4:00pm EDT

#650: Leading for Growth: Unlocking Individual Potential in Your Team
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
202AB
Component Type: WorkshopLevel: BasicCE: ACPE 1.00 Application UAN: 0286-0000-26-657-L04-P; CME 1.00; PDU 1.00 PMI 2166FWL0S0; RN 1.00This workshop equips leaders at all levels with adaptable, evidence-based tools to meet diverse team needs, boost motivation and performance, and strengthen retention through interactive discussions and hands-on activities.Learning Objectives Identify and adapt...
See More →
Speakers
avatar for Tamei Elliott

Tamei Elliott

Director, Global Scientific Content, DIA, United States
Tamei Elliott, MS, is the Director of Global Scientific Content at the Drug Information Association (DIA). She leads DIA’s global scientific content strategy, ensuring alignment with regulatory priorities, industry trends, and evolving stakeholder needs across regions. She also... Read More →
avatar for Jennifer Kim

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Associate Professor and Behavioral Scientist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on addressing health and work disparities in drug development, examining strategies and interventions that can... Read More →
avatar for Elizabeth Lange

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

VP & Head, RQC, Science, Policy & Intelligence (SPI), Novo Nordisk Inc., United States
Elizabeth Rosenkrands Lange is an experienced R&D policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency and... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Workshop

4:00pm EDT

#651: Regulatory CMC and Product Quality Hot Topics Discussion
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-636-L04-P; CME 1.00; RN 1.00This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality. Learning Objectives Discuss current regulatory CMC challenges, including the use of AI, digitization, and emerging...
See More →
Speakers
avatar for Kevin Fitzpatrick

Kevin Fitzpatrick

Senior Vice President, Quality Assurance, AbbVie, United States
Kevin Fitzpatrick is Senior Vice President of Quality Assurance at AbbVie. Kevin was appointed to his current role in June 2025 after serving as Vice President, Quality Assurance, Biologics. Kevin has been with AbbVie/Abbot for 26 years, supporting CMC strategy and execution of AbbVie’s... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States
Celeste Frankenfeld Lamm, Ph.D., is a Senior Director of Quality and Reg CMC Policy at Merck & Co., where she leads a team of policy professionals who work to capture and align subject matter expertise around manufacturing quality and regulatory science, and translate it into meaningful... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Forum |   03: Data-Tech-AI, Forum

4:00pm EDT

#652: Anvisa Townhall - From Backlogs to Breakthroughs: Building a Smarter Regulatory Future
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
107AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-666-L04-P; CME 1.00; RN 1.00This town hall will present Anvisa’s strategy to reduce backlogs, modernize regulatory processes, and integrate innovation and AI into decision-making. The session will explore how Brazil is building a more agile, risk-based, and globally connected regulatory system.Learning Objectives...
See More →
Speakers
avatar for Ana Carolina Moreira Marino Araujo

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil
Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →
avatar for Daniel R. Coradi de Freitas

Daniel R. Coradi de Freitas

GENERAL MANAGER, ANVISA, Brazil
Biologist, MSc in Genetics and Molecular Biology, PhD in Epidemiology, with continuous work in health surveillance since 2000 in technical and senior management roles. Former FETP (2004–2006), joined Anvisa in 2005, working in blood, tissues, cells and organs, cell therapy, health... Read More →
avatar for Adriane Alves de Oliveira

Adriane Alves de Oliveira

Deputy Head, Clinical Trials Office, ANVISA, Brazil
Health Regulation Expert with over 12 years of experience in the regulatory evaluation and oversight of non-clinical and clinical development of drugs and biological products. She is currently the Deputy Head of the Clinical Trials Office at Anvisa and a Good Clinical Practice (GCP... Read More →
DP

Diogo Penha Soares

Deputy Director, ANVISA, Brazil
MR

Maira Ribeiro de Souza

Expert, Division of Safety and Efficacy Assessment, ANVISA, Brazil
Industrial pharmacist with a degree from the Federal University of Ouro Preto, Master of Pharmaceutical Sciences from the Federal University of Ouro Preto (2012), and Ph.D. in Pharmaceutical Sciences from the Federal University of Rio Grande do Sul (2022). Currently, works as a Specialist... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

4:00pm EDT

#655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
201AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-640-L04-P; CME 1.00; RN 1.00This session will assess the evolving global rare disease regulatory landscape and examine global harmonization efforts. Panelists will include leaders from FDA, EMA, NORD, Global Genes and they will discuss how get medicines to patients faster. Learning Objectives Describe the evolving US...
See More →
Speakers
EM

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Corinne de Vries

Corinne de Vries

EMA liaison official to the US FDA, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. At EMA, she has headed the offices of Risk Management, Science and Innovation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Rare Disease & Special Populations,Regulatory
  • Tags Forum

4:00pm EDT

#656: Singapore Town Hall
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
112AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-668-L04-P; CME 1.00; RN 1.00The Singapore Town Hall will show case how Singapore's world-class regulatory environment creates compelling business value, showcasing innovative pathways, digital transformation initiatives, and strategic advantages that make Health Sciences Authority (HSA) registration essential for...
See More →
Speakers
avatar for Raymond Chua

Raymond Chua

Deputy Director of Medical Services, Health Regulation Group, Ministry of Health, Singapore
Adj A/Prof (Dr) Raymond Chua is a Registered Medical Practitioner and Public Health Specialist. He is currently the Deputy Director of Medical Services, Health Regulation Group to oversee the regulations of healthcare services and premises in Singapore, so as to safeguard public health... Read More →
WY

Wan Yee Goh

Senior Vice President and Head, Healthcare, Singapore Economic Development Board, Singapore
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

4:00pm EDT

#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: ForumLevel: BasicCE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P; CME 1.00; RN 1.00Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.Learning Objectives Demonstrate the need for a continuous...
See More →
Speakers
avatar for Megan Aragon

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States
Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer, United States
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →
avatar for Bennett Levitan

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States
Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →
DM

Diana Morgenstern

Head, Real World Evidence and Outcomes Research, Viatris, United States
Diana Morgenstern, MD, FACP is a general internist whose varied career includes depth and breadth in clinical practice, medical education, and strategic approaches to pharmaceutical industry medical affairs, including real world evidence generation to address care gaps. Dr. Morgenstern... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   01: ClinSafety-PV-RM, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-639-L04-P; CME 1.00; RN 1.00India’s recent regulatory, policy, and digital reforms are accelerating innovation, quality, and global collaboration. This town hall will highlight key updates shaping clinical research, medtech growth, and patient safety, and India’s rising global role.Learning Objectives Identify...
See More →
Speakers
SF

Shahin Fesharaki

Chief Scientific Officer, Lupin, United States
MF

Marc Franklin

CEO - North America, Cipla, United States
avatar for Vivek Ahuja, MD

Vivek Ahuja, MD

Program Chair, Executive Vice President, Pharmacovigilance, EVERSANA, India
Dr. Vivek Ahuja is a physician-turned pharmaceutical leader with 25 years of experience across pharmacovigilance, clinical research, public health, and technology. In 2005 he pioneered pharmacovigilance in India by establishing the first global PV unit at Ranbaxy. He is Executive... Read More →
RS

Rajeev Singh Raghuvanshi

Drug Controller General, Central Drugs Standard Control Organization, India
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum |   07: RegCMC-Product Quality, Forum

4:00pm EDT

#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
117
Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-641-L04-P; CME 1.00; RN 1.00This session explores AI's role in pharma, offers regulators' insights and Q&A, introduces a Gen AI validation framework, and showcases use cases in audit report authoring and process/knowledge management chatbot, highlighting ethical, time/cost efficient, and compliant AI adoption.Learning...
See More →
Speakers
KB

Karen Bleich

Lead Physician, OMP, CDER, FDA, United States
Dr. Bleich is a Lead Physician in the Division of Clinical Trial Quality and a member of the AI team within the Office of Medical Policy (OMP), CDER, FDA. In these roles, she drives clinical research quality and innovation through the development of medical policy programs and strategic... Read More →
SE

Srilatha Endabetla

Senior Director, Business Intelligence - Global Quality, Bristol Myers Squibb, United States
Srilatha Endabetla is a senior leader driving Business Intelligence and Digital & Data Strategies for Global Quality, with over 30 years of experience in digital transformation, data analytics, and data governance in the pharmaceutical industry. She has spent 23 years at Bristol Myers... Read More →
avatar for Oliver Fink

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim, Germany
HV

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States
Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   03: Data-Tech-AI, Session
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Feature Topics Artificial Intelligence
  • Tags Session

4:00pm EDT

#659: Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
203AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-642-L04-P; CME 1.00; RN 1.00This session highlights innovative Real World Data (RWD) methods, including AI, for enhancing Real World Evidence (RWE) for regulatory decisions. Through case studies and discussion, it will examine practical integration strategies for these innovations. Learning Objectives Define the...
See More →
Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Gracy Crane

Gracy Crane

Policy Lead, Roche, United Kingdom
Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →
OK

Olaf Klungel

Professor of Pharmacoepidemiologic Methods, Utrecht University, Netherlands
Olaf Klungel is Professor of Pharmacoepidemiologic Methods, chair of the division of Pharmacoepidemiology & Clinical Pharmacology and the scientific director of the Utrecht Institute for Pharmaceutical Sciences (UIPS) at Utrecht University. He is also member of the Methodology working... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#657: Great Science Isn’t Enough: Building Value Early in Emerging Biotech
Wednesday June 17, 2026 4:00pm - 5:15pm EDT
103A
Component Type: SessionLevel: IntermediateAs a closing session, this discussion brings together key themes from the day to examine how innovators can better connect science to market realities. It will highlight practical ways to optimize product value for investors, payers, and regulatorsLearning Objectives Understand the factors that shape product value; Identify critical early decisions...
See More →
Speakers
MK

Michael Kuchenreuther

Director Research & Analytics, Numerof & Associates, United States
MT

Mark Twyman

Senior Consultant & Engagement Manager, Numerof & Associates, United States
Wednesday June 17, 2026 4:00pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   18: Lift-Series, Session
 
Thursday, June 18
 

8:00am EDT

#700: Insights Regarding Implementation of the ASAP Process
Thursday June 18, 2026 8:00am - 9:00am EDT
118AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P; CME 1.00; RN 1.00We will focus on insights regarding implementation of the ASAP process, how it has been beneficial to implement, and results from a survey across a targeted sample of forward-thinking pharma companies (big and small).Learning Objectives Describe the steps to implement the ASAP process at...
See More →
Speakers
FH

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States
Famina Hemani, PharmD, is a Pharmacovigilance leader with over 20 years of experience in pharmacy and biopharma, including more than a decade in strategic safety leadership. She has built and scaled PV functions from early clinical development through pre-commercialization across... Read More →
FH

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States
avatar for Cynthia McShea

Cynthia McShea

Head, Safety Statistics, UCB Biosciences, United States
Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she... Read More →
SP

Shital Patel

Associate Safety Lead, UCB, United States
SP

Shital Patel

Associate Safety Lead, UCB Biosciences, United States
Thursday June 18, 2026 8:00am - 9:00am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session

8:00am EDT

#701: No Report Left Behind: Human-Centered Safety Reporting
Thursday June 18, 2026 8:00am - 9:00am EDT
103A
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P; CME 1.00; RN 1.00Human-centered safety reporting empowers participants to speak up sooner. This session explores how consent innovation, safety processes, and clinical operations partner to reduce missed reports, protect patients, and strengthen trial integrity.Learning Objectives Identify the key...
See More →
Speakers
avatar for Lani Hashimoto

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States
Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Jennifer Miller

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States
Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session

8:00am EDT

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision
Thursday June 18, 2026 8:00am - 9:00am EDT
109AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00As pharma companies set increasingly bold ambitions for productivity, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI, with humans working alongside agents.Learning Objectives Describe recent trends in...
See More →
Speakers
AD

Andrea Doyle

Global Regulatory Affairs NA Head, Sanofi, United States
Andrea Doyle is Global Regulatory Affairs Head of Region North America (NA) and Global Advertising and Promotion at Sanofi. She provides oversight and regulatory expertise to optimize development programs and leads Global Advertising and promotion to deliver dynamic solutions to support... Read More →
CG

Cassie Gregson

VP Head of AI Enterprise Process & Innovation Center, AstraZeneca, United States
avatar for Anton Mihic

Anton Mihic

Partner, McKinsey & Company, United States
Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →
RR

Ralf Raschke

Senior Expert, McKinsey & Company, United States
JX

Jennings Xu

Senior Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine, United States
Jennings Xu is Senior Director of Data Science at Johnson & Johnson, where he leads R&D Generative AI strategy, partners with Global Regulatory Affairs on end-to-end AI-enabled acceleration, and heads Asia-Pacific R&D Data Science. He oversees multidisciplinary teams across discovery... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   04: MedAffairs-SciComm, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
  • Feature Topics Artificial Intelligence
  • Tags Session

8:00am EDT

#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization
Thursday June 18, 2026 8:00am - 9:00am EDT
111AB
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P; CME 1.00; RN 1.00AI adoption in RA/QA is currently fragmented and uncertain, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives...
See More →
Speakers
avatar for Nicholas Capman

Nicholas Capman

President & CEO, The FDA Group, United States
Nicholas Capman is CEO of The FDA Group, where since 2007 he has led the company’s evolution from a specialized services firm into a service + software organization integrating AI-driven capabilities to strengthen FDA compliance. He is passionate about advancing innovation responsibly... Read More →
avatar for Benjamin Eloff

Benjamin Eloff

Vice President, Healthcare Innovation Catalysts, United States
Ben Eloff brings nearly 20 years of federal leadership in advancing medical innovation and regulatory science. At FDA, he pioneered the first Bayesian device trial and co-authored the agency’s real-world evidence guidance. He led the launch of public-private initiatives including... Read More →
avatar for Carrie Nielson

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States
Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →
avatar for Fatima Sabar

Fatima Sabar

CEO, Bluenote Health, United States
Fatima Sabar is the CEO & Founder of Bluenote. Bluenote’s AI Agents Platform for Life Sciences is driving 50-75% efficiency gains for scientists and engineers at the world’s leading biopharma, medical devices and diagnostics companies. The platform focuses on regulatory workflows... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   09: RD-Quality-Compliance, Session

8:00am EDT

#704: The View from the Top: What is the Future of Medical Writing?
Thursday June 18, 2026 8:00am - 9:00am EDT
105AB
Component Type: ForumLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-646-L04-P; CME 1.00; RN 1.00Senior regulatory writing leaders from top pharma companies will share a candid, strategic view of how medical/regulatory writing is evolving over the next 3–5 years. The panel will explore how technology (including AI and structured content), new regulatory pathways, and shifting operating...
See More →
Speakers
avatar for Elizabeth Brown

Elizabeth Brown

Executive Director, Clinical & Regulatory Strategic Communications, Merck & Co., Inc., United States
Elizabeth Brown is the Executive Director, Head of Clinical Transparency Communications at Merck & Co, Inc., where she oversees clinical trial registration and results disclosure, as well as health literacy deliverables (ICF/PLS). She has led people, projects, and initiatives in biopharma... Read More →
avatar for Krista Crenshaw

Krista Crenshaw

Sr. Director, Clinical Content Operations, Alcon, United States
Krista is the Senior Director of Clinical Content Operations at Alcon, leading a global organization of medical writers, QC specialists, and publications leads responsible for clinical trial documentation, regulatory submissions, and publications for devices and pharmaceuticals. With... Read More →
avatar for Joanne Hilton

Joanne Hilton

VP, Global Medical Writing, GlaxoSmithKline, United Kingdom
Joanne Hilton has over 25 years’ experience in medical communications across regulatory affairs, clinical development and medical affairs in large pharma as well as boutique agencies. She has a track record of building capabilities globally, delivering strategic growth, talent management... Read More →
avatar for Nancy Tam

Nancy Tam

Vice President and Head of Medical Writing, Pfizer, United States
Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy is passionate about the role of medical writers in clinical development and has been involved in a wide range of transformation... Read More →
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   06: ProfDevelop-Program-PortfolioMgmt, Forum
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication
  • Tags Forum

8:00am EDT

#705: Fighting Medical Disinformation (Without Actually Starting a Fight)
Thursday June 18, 2026 8:00am - 9:00am EDT
108A
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-647-L04-P; CME 1.00; PDU 1.00 PMI 2166KJ1ZXS; RN 1.00We’ll discuss whether drug development professionals have an ethical obligation to confront misinformation, effective ways to approach these conversations without confrontation, and what techniques and messages work best in different settings. Learning...
See More →
Speakers
JC

Joseph Cappella

Gerald R. Miller Professor Emeritus of Communication, University of Pennsylvania, United States
Joseph N. Cappella is the Gerald R. Miller Emeritus Professor of Communication at the Annenberg School for Communication. His research has resulted in more than 225 articles and four co-authored books. His research has been supported by grants from NIMH, NIDA, NSF, NCI, NHGRI, and... Read More →
SL

Sydney Lupkin

NPR Pharmaceutical Correspondent, National Public Radio (NPR), United States
Sydney Lupkin is the pharmaceuticals correspondent for NPR. Prior to NPR, she was a correspondent at Kaiser Health News, where she covered drug prices and specialized in data reporting for its enterprise team. She's reported on how tainted drugs can reach consumers, how companies... Read More →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In this role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Forum

8:00am EDT

#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis
Thursday June 18, 2026 8:00am - 9:00am EDT
118C
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-648-L04-P; CME 1.00; RN 1.00The session will show CMC data from an internal system can be transferred to a cloud environment. The session will include a demonstration of structured CMC submissions and show how AI-assisted tools can facilitate review and collaboration. Learning Objectives Illustrate a future state...
See More →
Speakers
avatar for Ciby Abraham

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States
Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
avatar for Omar Serang

Omar Serang

Chief Cloud Officer, DNAnexus, United States
General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   03: Data-Tech-AI, Session

8:00am EDT

#707: EMA - FDA Question Time
Thursday June 18, 2026 8:00am - 9:00am EDT
114
Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-667-L04-P; CME 1.00; RN 1.00In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.Learning...
See More →
Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Orla Moriarty

Orla Moriarty

Scientific Officer, European Medicines Agency, Netherlands
Orla Moriarty is a scientific officer in the Translational Sciences Office at EMA where she is responsible for providing scientific support to the Agency’s 3Rs and Non-clinical Working Parties. She joined EMA in 2023 as a Seconded National Expert from the Irish Health Products Regulatory... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Corinne de Vries

Corinne de Vries

EMA liaison official to the US FDA, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. At EMA, she has headed the offices of Risk Management, Science and Innovation... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Session

8:00am EDT

#708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22
Thursday June 18, 2026 8:00am - 9:00am EDT
102AB
Component Type: WorkshopLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-624-L04-P; CME 1.00; RN 1.00This workshop explores integrating patient preference studies into clinical trial design and drug application submissions, highlighting operational strategies, stakeholder collaboration, and how these align with the upcoming ICH E22 guideline.Learning Objectives Recognize key aspects of...
See More →
Speakers
avatar for Megan Aragon

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States
Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →
avatar for Leila Lackey

Leila Lackey

Director, Patient Preference Evidence Generation, Pfizer, United States
Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Currently, Dr. Lackey is a Director of Patient Preference Evidence Generation at Pfizer. In this role, she oversees patient... Read More →
avatar for Bennett Levitan

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States
Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Workshop

8:00am EDT

#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You
Thursday June 18, 2026 8:00am - 9:00am EDT
117
Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-649-L04-P; CME 1.00; RN 1.00How do we learn from PV compliance failures? This session will provide insights from across industry and from the regulators on how to identify, prioritise and effectively fix non-compliance in PV, exploring the role of psychological safety in this.Learning Objectives Describe how proactive...
See More →
Speakers
avatar for Anna Adams

Anna Adams

Head, PV QA Europe, Daiichi Sankyo Co., Ltd., United Kingdom
As a senior leader in PVQA at Daiichi Sankyo, Anna is passionate about fostering a strong Quality Culture. Her group manages pharmacovigilance inspection readiness and PV compliance oversight, with transparency and proactive collaboration. She was previously Head of Performance and... Read More →
MB

Manny Burga

Operations Executive, formerly J&J and Kenvue, Independent, United States
AC

Andrew Cooper

Senior Director Business Partnering PV, Regulatory and Medical R&D, GSK, United Kingdom
avatar for Helen Emery

Helen Emery

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Helen is a Pharmacovigilance Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA). Prior to joining the MHRA she spent several years in Industry, where she accumulated knowledge across the PV system. She held roles supporting the EU QPPV, which ultimately led... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   01: ClinSafety-PV-RM, Session
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Quality Assurance / Control & CMC
  • Tags Session

8:00am EDT

#710: Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities
Thursday June 18, 2026 8:00am - 9:00am EDT
107AB
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-650-L04-P; CME 1.00; RN 1.00Explore Good Clinical Practice Inspections (GCP) inspections from regulatory and industry views, using FDA data to highlight global trends, compliance strategies, and harmonization, with insights on coverage of sites, sponsors, clinical research organizations (CROs), and regions.Learning...
See More →
Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Dr. Kassa Ayalew serves as the Division Director for the Division of Clinical Compliance Evaluation within the Office of Scientific Investigation at the FDA’s Center for Drug Evaluation and Research. In this role, he oversees the evaluation of the integrity of efficacy and safety... Read More →
avatar for Thomas Haag

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC, United States
Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →
JL

Jong-Hoon Lee

Senior Physician, FDA, United States
Dr. Lee graduated from University of Virginia (BA; Charlottesville, VA) and Virginia Commonwealth University (MD; Richmond, VA), then completed internship at State University of New York at Syracuse (Internal Medicine; Syracuse, NY), residency at George Washington University (Anatomic... Read More →
IO

Izumi Oba

Inspection Deupty Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Thursday June 18, 2026 8:00am - 9:00am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Forum

8:00am EDT

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives
Thursday June 18, 2026 8:00am - 9:00am EDT
116
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P; CME 1.00; RN 1.00The session explores the integration of external data in clinical trials to enhance efficiency, reduce sample sizes, and shorten timelines. It covers methodological advances, regulatory perspectives, and best practices for using external controls.Learning Objectives Identify the nuances...
See More →
Speakers
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
PM

Pralay Mukhopadhyay

Vice President, Medicines Development Leader, Oncology R&D, GSK, United States
Dr. Mukhopadhyay has a proven track record in oncology drug development. He currently works as Vice President, Medicine Development Leader at GlaxoSmithKline. Over the years, he has made significant contributions in the development of several anti-cancer agents in both hematologic... Read More →
avatar for Kannan Natarajan

Kannan Natarajan

Senior Vice President, Head of Global Biometrics and Data Management, Pfizer, Inc., United States
Kannan Natarajan is the Global Head of Biometrics & Data Management and Chief Statistical Officer of Global Product Development at Pfizer. He is a member of the Global Product Development Leadership Team and Deputy Chair of the Clinical Development Board, a governance body that provides... Read More →
avatar for Satrajit Roychoudhury

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States
Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →
XW

Xiaofei Wang

Professor, Biostatistics & Bioinformatics, Duke University Medical Center, United States
Xiaofei Wang is Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and Director of Statistics at the Alliance Statistics and Data Management Center. He received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2003... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Evidence Innovation
  • Tags Forum

9:30am EDT

#712: FDA Town Hall
Thursday June 18, 2026 9:30am - 10:30am EDT
114
Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-652-L04-P; CME 1.00; RN 1.00In this session, senior leaders from the U.S. Food and Drug Administration (FDA) will provide an update on key priorities, including the Commissioner's National Priority Voucher Program, artificial intelligence in drug and biological product development, and the Agency's digital...
See More →
Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER Center for Clinical Trial Innovation (C3TI) and is part of the FDA team for Prescription Drug... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
MM

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States
KS

Katherine Szarama

Deputy Director, CBER, FDA, United States
JW

Jeremy Walsh

Chief AI Officer, OC, FDA, United States
Thursday June 18, 2026 9:30am - 10:30am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

11:00am EDT

#713: No More Incremental Change: The Radical Future of Healthcare
Thursday June 18, 2026 11:00am - 12:30pm EDT
114
Component Type: SessionLevel: IntermediateThis closing session brings together pioneering voices at the intersection of AI, advanced computing, and biopharma to explore how a new intelligence layer is rewiring the entire life sciences value chain—from discovery to delivery. The discussion will examine how foundational AI, cloud-scale infrastructure, and digital platforms are reshaping R&D,...
See More →
Speakers
avatar for Susan Furth

Susan Furth

Executive Vice President and Chief Scientific Officer, Children's Hospital of Philadelphia, United States
avatar for Carlos Garner

Carlos Garner

Senior Vice-President Global Regulatory Affairs and Head, Lilly Regenerative Med, Eli Lilly and Company, United States
Dr. Garner is executive leader for Global Regulatory Affairs for Eli Lilly and Company. The organization is responsible for the regulatory leadership, strategic and operational support for human drugs, medical devices, and global manufacturing for Eli Lilly and Company. Additionally... Read More →
avatar for Dhruv Jayanth

Dhruv Jayanth

Business Lead, Life Sciences, OpenAI, United States
avatar for Shweta Maniar

Shweta Maniar

Global Director, Strategic Industries - Life Sciences, Google, United States
Shweta leads Healthcare & Life Sciences Strategic Industries at Google Cloud, where she bridges the gap between cutting-edge technology and patient outcomes. A PharmaVoice 100 trailblazer, she is a seasoned innovator known for turning complex data ecosystems into collaborative engines... Read More →
avatar for Eli Weinberg

Eli Weinberg

Partner, Bain & Co., United States
Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... Read More →
Thursday June 18, 2026 11:00am - 12:30pm EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   00: Plenary, Session
 
Register to attend
  • Filter By Date
    Jun 8 - 18, 2026
  • Filter By Venue
    1101 Arch St, Philadelphia, PA 19107, USA
    All
    102AB
    103A
    105AB
    107AB
    108A
    108B
    109AB
    110A
    111AB
    112AB
    114
    115AB
    115C
    116
    117
    118AB
    118C
    119AB
    201AB
    202AB
    203AB
    204AB
    Ballroom AB
    Content Hub
    Exchange
    Innovation Theater 1
    Innovation Theater 2
    Innovation Theater 3
    Spark Stage
    TBD
    Zone A
    Zone B
  • Filter By Type
    00: Plenary
    All
    Session
    01: ClinSafety-PV-RM
    All
    Forum
    Session
    02: ClinicalTrialOps-Innovation
    All
    Forum
    Session
    Workshop
    03: Data-Tech-AI
    All
    Forum
    Session
    Workshop
    04: MedAffairs-SciComm
    All
    Forum
    Session
    Workshop
    05: PersonalizedMed-ComboProd-Diagnostics
    All
    Forum
    Session
    Workshop
    06: ProfDevelop-Program-PortfolioMgmt
    All
    Forum
    Session
    Workshop
    07: RegCMC-Product Quality
    All
    Forum
    Session
    Tutorial
    Workshop
    08: RegPolicy-Strategy-GlobalCollaboration
    All
    Forum
    Session
    Workshop
    09: RD-Quality-Compliance
    All
    Forum
    Session
    10: Stats-EvidenceGeneration-RWE
    All
    Forum
    Session
    Tutorial
    11: Spark Stage
    All
    Session
    12: Content-Hubs
    All
    Workshop
    13: Community-Rounds
    All
    Session
    14: Posters
    All
    Session
    15: Networking-Opportunities
    All
    Session
    16: InnovationTheaters
    All
    Session
    17: Short-Courses
    All
    Tutorial
    18: Lift-Series
    All
    Session
    Workshop
  • Audience
    Advanced
    Basic
    Intermediate
  • Area
    Artificial Intelligence
    Biotech-ClinTech-Pathway
    Cross-Functional Collaboration
    Digital Enablement and Modernization
    Ethics
    Evidence Innovation
    Global Alignment in Practice
    Patient-Centered Design and Experience
    Student and Early Career Pathway
    Therapeutic Pathways
    Trust and Responsible Innovation
  • Timezone
DIA 2026 Global Annual Meeting
Register to attend

Get help with the event

Contact event planner Event login
View support guides Find upcoming events
Create an event you'd love to attend!
Explore why organizers choose Sched • Success stories
Event App • Event scheduling • Event registration • Event ticketing • Sched forms • Call for papers • Badges • Conferences
© 2026. SCHED LLC - All rights reserved - Helping events since 2008
Meeting Planning Software • Privacy • Terms
Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Monday, June 8
Monday, June 15
Tuesday, June 16
Wednesday, June 17
Thursday, June 18
102AB
103A
105AB
107AB
108A
108B
109AB
110A
111AB
112AB
114
115AB
115C
116
117
118AB
118C
119AB
201AB
202AB
203AB
204AB
Ballroom AB
Content Hub
Exchange
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
Spark Stage
TBD
Zone A
Zone B
  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
  • 07: RegCMC-Product Quality
  • 08: RegPolicy-Strategy-GlobalCollaboration
  • 09: RD-Quality-Compliance
  • 10: Stats-EvidenceGeneration-RWE
  • 11: Spark Stage
  • 12: Content-Hubs
  • 13: Community-Rounds
  • 14: Posters
  • 15: Networking-Opportunities
  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
  • Intermediate
  • Area
  • Artificial Intelligence
  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation