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Pharmacovigilance and Risk Management Strategies Conference


Session 7: RWE With a Global Perspective

Session Chair(s)

Mariette  Boerstoel-Streefland, MD, MBA, MS

Mariette Boerstoel-Streefland, MD, MBA, MS

  • Senior Vice President Global Drug Safety
  • Alexion Pharmaceuticals, Inc., 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

Next Generation Approaches for Ever More Effective Leverage of Real World Data

Andrew Bate, PhD, MA

  • Head of Safety Innovation and Analytics
  • GlaxoSmithKline, United Kingdom
David  Martin, MD, MPH

FDA Perspectives on use of RWE for Evidence Generation in US

David Martin, MD, MPH

  • Associate Director for Real World Evidence Analytics, OMP, CDER
  • FDA, United States
Hans-Georg  Eichler, MD, MSc

Overcoming Methodology Aversion in Drug Development and Regulation

Hans-Georg Eichler, MD, MSc

  • Senior Medical Officer
  • European Medicines Agency, Netherlands