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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
Executive Director, Real-World Evidence
PPD, part of Thermo Fisher Scientific, 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)
Speaker
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
Speaker
Xavier Kurz, MD, PhD, MSc
European Medicines Agency, Netherlands
Head of Data Analytics Workstream
Speaker
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director