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Session 9: Shaping the Future of Real-World Data and Evidence Through Policy and Collaboration
Session Chair(s)
Jaclyn Bosco, MPH, FISPE
Vice President & General Manager, Global Head of Epidemiology & Scientific Strat, IQVIA, United States
As real-world data and evidence (RWD/E) become increasingly central to regulatory decision-making, evolving policies, technologies, and legal frameworks shape their future use. This session will be a fire-side chat with a panel that brings together perspectives from regulators, and the biopharmaceutical industry, and real-world data and analytics organizations to discuss key issues including data quality, AI integration, transparency, data standards, innovative trial designs, and international harmonization. Attendees will gain insights into collaborative efforts driving the next-generation RWD/E framework amid a dynamic regulatory and policy landscape.
Learning Objective : - Explain key policy and regulatory considerations affecting the use of RWD/E in regulatory decision-making
- Recognize the importance of data standards, transparency, and international harmonization in advancing RWD/E frameworks
- Assess the role of emerging technologies, including AI, in analyzing and leveraging real-world data
Speaker(s)
Motiur Rahman, PHD, MPHARM, MS
Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Speakers
Ulka B Campbell, PHD
Head of Scientific Strategy, Aetion Inc, United States
Speaker
Trevan Locke, PHD
Director, Global Regulatory Policy and Intelligence, Amgen, United States
Speaker
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