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