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Session 7: RWE With a Global Perspective
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer , Bristol Myers Squibb, 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)
Andrew Bate, PHD, MA
Vice President, Head of Safety Innovation and Analytics, GSK, United Kingdom
Next Generation Approaches for Ever More Effective Leverage of Real World Data
David Martin, MD, MPH
Vice President, Head, PCO Center of Excellence, Novartis, United States
FDA Perspectives on use of RWE for Evidence Generation in US
Hans-Georg Eichler, MD, MSC
Consulting Physician, Austrian Association of Social Security Bodies, Austria
Overcoming Methodology Aversion in Drug Development and Regulation