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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: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P; CME 1.00; RN 1.00

We 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 a smaller company with limited resources; Identify specific effficiencies achieved when applying the ASAP process to platform products or product families with shared componentts; Recognize how the ASAP process has been beneficial to implement for various projects.

Chair

Greg Ball, PHD

Speaker

Insights Regarding Implementation of the ASAP Process
Barbara Hendrickson, DrMed, MD

Advantages of Earlier Systematic and Strategic Safety Planning
Famina Hemani, PHARMD

Practical Implementation of ASAP Concepts
Shital Patel, PHARMD

Practical Implementation of ASAP Concepts
Cynthia McShea, MPH


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: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P; CME 1.00; RN 1.00

Human-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 factors that contribute to patients underreporting adverse events and assess the resulting impact on safety, operations, and compliance; Describe approaches for applying human-centered strategies—such as engaging people living with the condition and using ongoing comprehension checks—to clarify reporting expectations; Evaluate site-level and technology-enabled practices that support more complete and timely reporting.

Chair

Lani Hashimoto

Speaker

Panelist
Stacy Hurt, MBA, MHA

Panelist
Jennifer Miller, PHD


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: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00

As 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 regulatory submission preparation acceleration, including role of technology; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.

Chair

Anton Mihic, MSC

Speaker

Agentic AI for statistical programming and rapid biostatistical analysis
Ralf Raschke

Panel discussion: Learnings from AI-enabled clinical and regulatory decision making
Jennings Xu

Panel discussion: Learnings from AI-enabled regulatory submissions
Cassie Gregson

Panel discussion: Learnings from AI-enabled end-to-end dossier generation
Andrea Doyle


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: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P; CME 1.00; RN 1.00

AI 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 will gain a clear framework for making confident, risk-aware AI decisions now and as the landscape matures.

Learning Objectives

Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable; Differentiate near-term AI actions, deferred investments, and avoidable risks using a category-driven lens; Apply a practical framework to guide compliant, defensible AI decisions across quality and regulatory functions.

Chair

Nicholas Capman, MBA

Speaker

Considerations for AI tool validation and implementation
Benjamin C Eloff, PHD

Pragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human Control
Fatima Sabar, MSC

AI and the Path to Submission Ready RWE: Enabling Compliance and Data Quality
Carrie Nielson, MPH


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: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-646-L04-P; CME 1.00; RN 1.00

Senior 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 models are redefining writer responsibilities, team structures, and the value writers bring to development programs. Attendees will leave with clear insights on future-ready skills and practical steps to position regulatory writing as a critical driver of regulatory and clinical success.

Learning Objectives

Describe leadership-level forecasts for the medical/regulatory writing function over the next 3–5 years, including key forces driving change; Identify how top pharma organizations are redefining the role and value of regulatory writers; Explain the implications of technology adoption on writer responsibilities, quality oversight, and team structures.

Chair

Robin Whitsell

Speaker

Panelist
Elizabeth Brown, MS, PMP

Panelist
Krista Crenshaw, MS

Panelist
Nancy Tam, MS

Panelist
Joanne Hilton, MBA


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: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-647-L04-P; CME 1.00; PDU 1.00 PMI 2166KJ1ZXS; RN 1.00

We’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 Objectives

Explain the ethical principles that underlie the obligation of drug development professionals to combat disinformation; Discuss best practices for successful encounters in combatting disinformation; Distinguish the application of different practices in their most appropriate settings

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Perspectives of a Science Reporter
Sydney Lupkin

Effective Messaging to Combat Scientific Mis/Disinformation
Joseph N Cappella, PHD


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: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-648-L04-P; CME 1.00; RN 1.00

The 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 in which CMC data from internal systems can be seamlessly transferred to a cloud environment; Demonstrate a structured CMC submission and show how AI-assisted tools can facilitate review and collaboration between industry and regulators.

Chair

Ciby Joseph Abraham, PHD

Speaker

Panelist
Vada Perkins, MS

Panelist
Omar Serang


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: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-667-L04-P; CME 1.00; RN 1.00

In 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 Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Corinne de Vries, PHD, MA, MSC

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Orla Moriarty, PHD

Panelist
Joaquim Berenguer Jornet, MS


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: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-624-L04-P; CME 1.00; RN 1.00

This 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 patient preference studies (PPS) design using a practical, interactive preference elicitation example; Describe how to incorporate PPS into clinical trial design and regulatory decisions using insights from ICH E22; Identify key operational strategies and challenges in designing PPS.

Chair

Bennett Levitan, MD

Speaker

Patient Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Megan Aragon, MBA

Regulatory Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Robyn Bent, BSN, MS, RN

Industry Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Leila Lackey, MHS, PHD


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: 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
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: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-650-L04-P; CME 1.00; RN 1.00

Explore 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 Objectives

Recognize FDA GCP inspection scope and trends from FY2016–2018 across US and non-US sites; Compare inspection approaches among regulators; Evaluate opportunities for harmonization and information sharing; Analyze industry strategies for global inspection readiness and compliance.

Chair

Kassa Ayalew, MD, MPH

Speaker

panelist
Thomas Haag

Panelist
Izumi Oba

Panelist
Jong-Hoon Lee, MD


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: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P; CME 1.00; RN 1.00

The 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 while integrating external data in trial design and analysis; Evaluate regulatory requirements and perspectives; Discuss the possibility of external control trial in their organization.

Chair

Satrajit Roychoudhury, PHD

Speaker

Panelist
Xiaofei Wang, PHD

Panelist
Scott Berry, PHD

Panelist
Kannan Natarajan, PHD

Panelist
Pralay Mukhopadhyay, PHD


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: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-652-L04-P; CME 1.00; RN 1.00

In 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 transformation efforts. The session will provide the opportunity for the audience to ask questions.

Learning Objectives

Discuss FDA’s key initiatives and strategic priorities; Identify opportunities for engagement with FDA regulators.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
R. Angelo De Claro, MD

Panelist
Katherine Szarama

Panelist
Jeremy Walsh

Panelist
Mallika Mundkur, MD, MPH


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: Session
Level: Intermediate

This 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, clinical development, manufacturing, and patient engagement. The conversation will highlight not only breakthrough opportunities—smarter target discovery, more adaptive trials, real-world evidence at scale, and hyper-personalized care—but also the governance, ethics, workforce, and partnership models needed to harness these technologies responsibly in a highly regulated environment.

Learning Objectives

Describe key ways AI and other advanced digital technologies are reshaping the life sciences value chain; Discuss concrete examples of how leading pharma and tech companies are using digital platforms, cloud infrastructure, and AI to accelerate R&D and improve patient outcomes; Evaluate key risks and governance challenges associated with deploying powerful AI and data technologies in regulated life sciences settings, including bias, transparency, and accountability.

Chair

Eli Weinberg, PHD, MS

Speaker

Panelist
Susan Furth, MD, PHD

Panelist
Carlos Garner, PHD, MSC

Panelist
Dhruv Jayanth

Panelist
Shweta Maniar


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
 
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DIA 2026 Global Annual Meeting
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TBD
Zone A
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  • 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
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  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
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  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
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  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation