DIA 2026 Global Annual Meeting: Full Schedule

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

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P; CME 1.25; RN 1.25

This 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 different data sources for safety surveillance across the healthcare landscape in the future; Identify the challenges for data collection, monitoring and assessment of safety data from evolving real world use of healthcare products; Discuss the opportunities this represents for vigilance and how to deliver greater impact on patient care.

Chair

Alison Cave

Speaker

Panelist
Phil Tregunno

Panelist
Angela Radcliff

Speakers

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 →

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States

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

#407: The Great Debate: Using AI in Patient-Facing Materials

Monday June 15, 2026 11:00am - 12:15pm EDT

105AB

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-515-L04-P; CME 1.25; RN 1.25

Artificial 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 “Great Debate” session, two industry presenters will offer contrasting perspectives on whether AI should directly generate or refine patient communications and will share practical examples of technologies being used today. A patient advocate will ground the discussion in real-world needs and expectations, helping participants leave with actionable guardrails for adopting AI responsibly and keeping patients at the center.

Learning Objectives

Discuss the role of AI in patient-facing materials and practical guardrails; Identify key benefits and limitations of AI-enabled communication workflows in the pharmaceutical industry; Assess ethical and trust considerations for AI-influenced patient communications—such as transparency, bias, inclusivity, empathy, and the potential for misinformation—through both industry and patient-advocate lenses.

Chair

Regina Lynn Preciado

Speaker

The Great Debate: Using AI in Patient-Facing Materials
Christine Marie Von Raesfeld

The Great Debate: Using AI in Patient-Facing Materials
Kimbra Edwards, PHD

The Great Debate: Using AI in Patient-Facing Materials
Irene Kuhlman, MS

Speakers

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 →

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 →

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 →

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

#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: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P; CME 1.25; PDU 1.25 PMI 216641I1NS; RN 1.25

In 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 of the quality assurance professional in the age of AI and how to align with emerging expectation; Apply project management principles to strategically plan and execute your personal upskilling journey in AI; Discuss how to build a personalized career roadmap using practical tools and frameworks to stay relevant, resilient, and future-ready.

Chair

Michael Pelosi, MA, MBA

Speaker

Smarter Roles, Stronger Skills: AI in Workforce Evolution
Haleh Valian, PHD

Compliance to Competence: How AI and New Regulations Are Reshaping the Quality Professional
Jeremy Jones, MS

Quality in the Age of Agents: A Look Back From the AI-Driven Future
Roshan D'Souza

Speakers

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 →

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 →

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.

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

#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: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25

This 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 posting Complete Response Letters (CRLs); Analyze trends in CRLs over the past year, including common reasons for issuance; Evaluate the benefits and potential drawbacks of public CRL disclosure.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Eva Temkin, LLM

Panelist
Amanda Conti

Panelist
Eric Gascho

Speakers

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 →

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States

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 →

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

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions

Monday June 15, 2026 4:00pm - 5:00pm EDT

202AB

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00

Mentorship 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 using interactive cases; Differentiate mentorship from management; Apply the REAL framework to build inclusive, flexible, lasting mentoring relationships.

Chair

Carol Morales

Speaker

Mentorship Myth Busters: The Court of REAL Mentorship
Leslie Sam

Mentorship Myth Busters: The Court of REAL Mentorship
Tywnia Brewton

panelist
Sabhorak Horn, PHARMD, MBA, RPH

Speakers

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 →

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 →

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 →

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

Audience Basic
Area Student and Early Career Pathway
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Student and Early Career Pathway
Tags 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: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00

Explore 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 overview of the development and utilization of surrogate endpoints in FDA approvals; Examine the increasing reliance on surrogates, particularly case studies in fields like rare diseases and oncology, where overall survival data may be years away; Discuss ways to incorporate the patient and provider perspective to understand what constitutes “meaningful” endpoints.

Chair

Bridget Doherty, MPH, MS

Speaker

Panelist
Kara Berasi, PHARMD, MS

Panelist
Jenny Myers Ahlstrom

Panelist
Alexis Reisin Miller, JD

Speakers

Jenny Ahlstrom

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

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 →

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 →

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 →

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

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: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P; CME 1.25; RN 1.25

This 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 personas can augment real patient input to personalize and improve patient trial experience; Identify the data requirements and limitations for building synthetic AI personas.

Chair

Robina Weermeijer

Speaker

Panelist
Jason Binder, MA

Panelist
Himanshu Manchanda, PHD

Panelist
Sabina Kineen

Speakers

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 →

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 →

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany

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

Audience Basic
Area Artificial Intelligence, Patient-Centered Design and Experience
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Patient Engagement
Feature Topics Artificial Intelligence,Patient-Centered Design and Experience
Tags 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: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-573-L04-P; CME 1.25; RN 1.25

AI 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 AI requires foundational data, content, and process governance; Design governance mechanisms that align data standards (IDMP, CDISC) with structured content management principles; Evaluate regulatory expectations and industry hurdles related to data integrity, reliance, and trust in AI-driven or assisted processes; Assess and address organizational gaps that limit AI deployment.

Chair

Vanni Carapetian, MPH

Speaker

Industry Perspectives on AI + Governance: Policy
Andrew Robertson, JD, PHD

Industry Perspectives on AI + Governance: Tech
Jeff Steinke

Industry Perspectives on AI + Governance
Vada Perkins, MS

Speakers

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 →

Vanni Carapetian

CMC RA, Strategy and Operations, Executive Director, Gilead Sciences, Inc, United States

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 →

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 →

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

Audience Basic
Area Artificial Intelligence, Global Alignment in Practice
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Health Technology & AI
Feature Topics Artificial Intelligence,Global Alignment in Practice
Tags 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: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-582-L04-P; CME 1.00; RN 1.00

A 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 and opportunities that could present for patients from having early access to information on safety signals arising from spontaneous data from international regulators; Assess how patient preferences can be evaluated and incorporated in safety monitoring and risk management communications.

Chair

Sarah Vaughan

Speaker

Panelist
Michael Mittelman

Panelist
Peter Hjelmstrom, MD, PHD

Panelist
Lisa Wolf, PHARMD

Speakers

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 →

Michael Mittelman

Chairman, American Living Organ Donor Fund, United States

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 →

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: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-584-L04-P; CME 1.00; RN 1.00

This 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 low trial capacity programs at community cancer centers in conducting clinical research; Recognize the role of professional training in preparing community cancer centers to implement clinical trials; Integrate learnings from a training pilot that helped advance foundational knowledge and confidence among clinic healthcare staff.

Chair

David Vulcano Landis, MBA

Speaker

Panelist
Ruma Bhagat, MPH

Panelist
Pete Fronte, MBA

Speakers

Ruma Bhagat

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

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 →

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 →

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

#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: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-589-L04-P; CME 1.00; RN 1.00

This 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 for the exponential growth in the distribution of unapproved or unauthorized medicines; Identify risks associated with illegal large-scale manufacturing of unregulated and untested compounded drugs; Discuss regulator perspectives on the issues relating to the mass distribution of unapproved medicines; Explain current regulatory frameworks and how to adapt them.

Chair

Brad Jordan, PHD

Speaker

TBD
Shabbir Safdar

Panelist
Andrew Funk, PHARMD, RPH

ANVISA Perspective
Renato Lopes Hurtado, MSC, RPH

Speakers

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 →

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 →

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.

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

Audience Basic
Area Therapeutic Pathways
Level Basic
format csv
Credit Type ACPE, CME, RN
Feature Topics Therapeutic Pathways
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: Forum
Level: Basic

Despite 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 and differentiate value across sponsors, payors, and patients; Identify opportunities to enhance trust and build collaborative infrastructure (core governance, incentives, data); Apply cross-sector and emerging data collaboration lessons to pilot and scale solutions.

Chair

Van Crocker

Speakers

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

#609: Decision Under Uncertainty

Wednesday June 17, 2026 10:15am - 11:30am EDT

203AB

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-603-L04-P; CME 1.25; PDU 1.25 PMI 2166LODLKY; RN 1.25

In 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 commonly used in business school programs. In this simulation, participants decide whether to race in a high-stakes event, balancing technical risks, financial pressures, and limited data, highlighting decision-making under uncertainty. The exercise addresses key issues in decision-making under uncertainty and bias without awareness under time and stakeholder pressure. Upon conclusion of the exercise, participants report increased awareness of decision drivers, stronger analytical skills, and strategies to mitigate bias.

Learning Objectives

Demonstrate teamwork and communication under time constraints; Identify biases when making decisions under financial pressure; Assess technical, financial, and reputational risks in complex business situations.

Chair

Valerie Huh, PHARMD, MBA

Speaker

Decision under uncertainty
Dave Bezick, RN

Speakers

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 →

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: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-604-L04-P; CME 1.25; PDU 1.25 PMI 2166GIDLXI; RN 1.25

Link 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 how common dysfunction signals relate to hidden beliefs and protective routines in team culture; Apply a step-by-step, unbranded mapping method to translate dynamics like low trust or weak accountability into testable insights; Design small, safe-to-learn experiments with lightweight indicators to build trust, productive debate, commitment, and accountability.

Chair

John Z. Sun, PHD, MBA, PMP

Speaker

Panelist
Jeremy Jokinen, MS

Panelist
Sarah Tremethick

Panelist
John Dobbins, MS

Panelist
Jessie Li

Speakers

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 →

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 →

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 →

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 →

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

#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: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-607-L04-P; CME 1.25; RN 1.25

The 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 analysis

Learning Objectives

Discuss the fundamental framework and eligibility criteria of the CNPV program; Analyze real implementation challenges and successful strategies; Evaluate the program's impact on expediting critical drug development and public health priorities.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Emel Mashaki Ceyhan

Panelist
Lawrence Eugene Liberti, RAC

Panelist
Kellie Taylor

Speakers

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States

Emel Mashaki Ceyhan

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

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 →

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 →

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States

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

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: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-633-L04-P; CME 1.00; RN 1.00

Siloed 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 Computing and its related components; Examine traditional data centralization methods with decentralized federated approaches; Identify use cases for Federated AI in drug discovery and development.

Chair

Ittai Dayan, MD, MPH

Speaker

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Jonathan Gilbert

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Nadia Harhen

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Kyle Tretina

Speakers

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 →

Jonathan Gilbert

Senior Director, Ecosystem Growth and Contributor Partnerships, Eli Lilly and Company, United States

Nadia Harhen

General Manager, AI Simulation, SandboxAQ, United States

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

#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: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-635-L04-P; CME 1.00; RN 1.00

Multi-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 participation and evidence generation.

Learning Objectives

Identify scientific, operational and regulatory factors driving the growing significance of long-term follow-up (LTFU) in gene therapy; Compare stakeholder challenges and solutions in sustaining LTFU participation and data quality for gene therapy programs; Evaluate strategies to strengthen accountability and align incentives to ensure sustained LTFU participation.

Chair

Alen Agaronov, DRSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Dennis Akkaya

Panelist
Carolyn Riley Chapman, PHD

Speakers

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 →

Dennis Akkaya

Corporate Development, My Tomorrows, United States

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 →

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

Audience Basic
Area Evidence Innovation, Therapeutic Pathways
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Rare Disease & Special Populations
Feature Topics Evidence Innovation,Therapeutic Pathways
Tags 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: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-657-L04-P; CME 1.00; PDU 1.00 PMI 2166FWL0S0; RN 1.00

This 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 leadership practices to different employee needs, backgrounds, and motivations; Discuss personalized growth opportunities that align with organizational goals; Demonstrate coaching and feedback skills that empower employees to own their growth journey.

Chair

Jennifer Kim, PHD

Speaker

Removing siloes and increasing information transparency in interdependent teams
Tamei Elliott, MS

Which inclusive leadership behavior matters the most for improving employee outcomes?
Elizabeth Lange, MPH, MS

Speakers

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 →

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 →

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States

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

#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: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P; CME 1.00; RN 1.00

Benefit-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 approach to benefit-risk planning; Recognize the risks of failing to conduct benefit-risk planning; Identify ways to introduce benefit-risk planning into drug development

Chair

Claudia Ana Ianos, MD

Speaker

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Robyn Bent, BSN, MS, RN

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Diana Morgenstern, MD, FACP

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Megan Aragon, MBA

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Bennett Levitan, MD

Speakers

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 →

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 →

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 →

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 →

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

#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: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-641-L04-P; CME 1.00; RN 1.00

This 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 Objectives

Identify regulatory expectations for implementing Generative AI in the pharmaceutical industry, focusing on practical applications such as structured authoring of audit reports, Generative AI validation frameworks, and AI-powered chatbots for knowledge management; Discuss the challenges, user experiences, cost efficiency, and compliance considerations involved in integrating AI into regulated environments.

Chair

Oliver Fink, MS

Speaker

Framework for computer system validation of Gen AI
Haleh Valian, PHD

Regulators expecatations and insights into Gen AI
Karen Bleich, MD

Gen AI-powered structured authoring for audit reports
Srilatha Endabetla, MS

Speakers

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 →

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 →

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim, Germany

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States

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

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: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-649-L04-P; CME 1.00; RN 1.00

How 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 approaches to investigating known issues, using a better understanding of psychological safety and learning from failure can help identify deeper root causes for future proofing compliance within the PV system; Explain how to build a proactive business case for identifying and addressing quality issues within the pharmacovigilance (PV) system and outline practical steps for initiating this work.

Chair

Anna Adams, PHD

Speaker

Panelist
Manny Burga

Panelist
Andrew Cooper

Panelist
Helen Emery

Speakers

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 →

Manny Burga

Operations Executive, formerly J&J and Kenvue, Independent, United States

Andrew Cooper

Senior Director Business Partnering PV, Regulatory and Medical R&D, GSK, United Kingdom

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

DIA 2026 Global Annual Meeting

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