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Session 1: A Year in Review of Advancing RWE Globally
Session Chair(s)
Keri Monda, PHD, MS
Executive Director, Center for Observational Research, Amgen, United States
Rachele Hendricks-Sturrup, MA
Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States
Over the past year, global regulatory bodies have released pivotal guidance and launched key initiatives shaping the future of Real-World Evidence (RWE). This session will feature updates on EMA’s DARWIN EU activities, FDA’s latest guidance and submissions involving real-world data (RWD), and progress on ICH M14. Panelists will also highlight the publication of new RWE-related standards and their implications for regulatory and payer decision-making. Insights will focus on how these developments are influencing industry strategies and evidence generation practices.
Learning Objective : - Discuss key 2024 RWE milestones from global regulators including EMA, FDA, and ICH
- Interpret new standards and guidance shaping the regulatory and payer use of RWE
- Examine how recent regulatory developments are shaping industry approaches to evidence generation and submission
Speaker(s)
Speaker
Vice President, Global Epidemiology, CMO, R&D, GSK, United States
Speaker
Founder and Chief Executive Officer, Verantos, United States
Speaker
, Pharmaceuticals and Medical Devices Agency (PMDA) Office of Drug Safety I, Japan
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