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Video

Plenary Session

Session: Keynote Plenary

Town Hall: Global Regulatory Forum on Real-World Evidence; Sponsored by ISPE's RWE Collaborative SIG

Friday, August 25, 2023
8:15 AM – 10:00 AM ADT
Location: Ballroom
Publication Number:
This session provides a novel opportunity for ISPE membership to interact with international regulators on scientific ‎initiatives and current approaches around the use of Real-World Data and Real-World Evidence to inform regulatory ‎decision making as it pertains to pharmacoepidemiology. The new town hall format invites officials from Health Canada ‎and the U.S. FDA to set the stage with a fireside chat to discuss key issues facing the field. The international discussion ‎continues with applied RWD examples within specific therapeutic areas including oncology, rare diseases, and ‎infectious diseases, concluding with an interactive panel discussion among global regulators moderated by the FDA ‎Commissioner.‎

‎* The objective is to facilitate an engaging discussion between ISPE and global regulatory agencies on high impact RWD ‎topics that are at the intersection of regulatory science and pharmacoepidemiology.‎

Learning Objectives: ‎
‎1. Provide a collaborative forum to hear an exchange of ideas among regulatory agencies, academia, industry, and ‎other stakeholders.‎
‎2. Illustrate examples of use of RWD and current RWE initiatives by global regulatory agencies.‎
‎3. Explore opportunities and challenges using RWD to support global regulatory science research and regulatory ‎decision-making.‎

Session Chair: Donna Rivera PharmD., MSc., Oncology Center of Excellence, U.S. Food and Drug Administration

‎Fireside Chat‎
Robert Califf, MD, Commissioner, US Food and Drug Administration
Pamela Aung-Thin, Assistant Deputy Minister, Health Canada
Moderated by: Brian Strom, MD, MPH, Chancellor, Rutgers Biomedical and Health Sciences, Rutgers University

‎Panel‎
Donna Rivera PharmD., MSc., Oncology Center of Excellence, U.S. Food and Drug Administration
Melissa Kampman, PhD., Manager, Data Analytics and Real-world Evidence Division, Health Canada‎
Yoshi Uyama, PhD., Director, Office of Epidemiology, Japan Pharmaceuticals and Medical Devices Agency
Michal Hirsh-Vexberg, MD, Head of the Drug Registration, Israeli Ministry of Health‎
Patrice Verpillat, Health of Real-World Evidence, European Medicines Agency
Katherine Donegan, PhD, Head of Epidemiology, Medicines and Healthcare products Regulatory Agency, UK

Moderated by: Robert Califf, MD, Commissioner, US Food and Drug Administration