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Session 2: What’s New in RWE Generation? A Global Regulatory Update
Session Chair(s)
Marni Hall, PHD, MPH
Vice President and General Manager, Global Regulatory Science and Strategy , IQVIA, United States
Delphine Saragoussi, MD, MSC
Head of Pharmacoepidemiology Vaccines, Sanofi, France
This session will bring together regulatory leaders from the United States, Europe, and Japan to discuss the evolving regulatory landscape for RWE, and related emerging topics. Speakers will address forward -looking priorities, opportunities, and trends, by region, including their current thinking, latest trends, regulations, and guidance. Lessons learned from expanded use of RWE during the COVID-19 pandemic will also be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify lessons learned from the use of RWE by regulators to inform the pandemic response
- Describe at least three trends in the use of RWE for regulatory decision making
- Compare RWE regulatory frameworks in three major geographies
Speaker(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Speaker
Xavier Kurz, MD, PHD, MSC
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
Speaker
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker
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