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Session 7: RWE With a Global Perspective
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, United States
This session will provide various perspectives on the increasing role of RWE in drug safety. It will give an overview of utilization of external data sources for routine RWE generation and opportunities for more extensive, credible, and impactful use of RWD. In addition, insights on regulatory perspectives on the use of RWE for safety assessments will be shared.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Appreciate utility of RWD for evidence generation
- Understand new approaches and opportunities to use RWE for safety assessment
- Get insight how regulators appreciate RWE in drug safety
Speaker(s)
Next Generation Approaches for Ever More Effective Leverage of Real World Data
Andrew Bate, PhD, MA
GlaxoSmithKline, United Kingdom
Vice President, Head of Safety Innovation and Analytics
FDA Perspectives on use of RWE for Evidence Generation in US
David Martin, MD, MPH
Moderna, United States
Vice President, Global Head RWE
Overcoming Methodology Aversion in Drug Development and Regulation
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
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