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Opening Remarks and Session 6: Objectivity and Transparency: Roundtable Discussions on Real-World Studies to Support Regulatory Decision-making
Session Chair(s)
Sarah Martin, PHD, MS
Senior Director - Global Regulatory Policy (Americas), Eli Lilly and Company, United States
Opening Remarks and Session 6: Objectivity and Transparency: Roundtable Discussions on Real-World Studies to Support Regulatory Decision-making
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss opportunities and challenges with the use of RWE for regulatory decision making
- Explain ‘objectivity’ in the context of real-world (RW) studies and why it is important, and how emulating the scientific and operational processes from a gold-standard randomized, controlled clinical trial helps maintain objectivity in RW studies
Speaker(s)
Real-world Studies to Support Regulatory Decision-making: The What and the How?
Director, Center for Observational Research, Amgen, United States
Trial Emulation Beyond Study Design: Meeting Regulatory Standards for Objectivity in Real-World Studies
Senior Director of Biostatistics, Aetion, United States
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