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Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact
Learning Objective : Define the key challenges and limitations in the use of real-world evidence (RWE) for regulatory decision-making; Illustrate how innovative methodologies can be integrated into study design and analysis to enhance the robustness and credibility of RWE; Describe practical insights, informed by multi-stakeholder perspectives, for developing a framework of regulatory acceptability of RWE.
Speaker(s)
Alison Cave, PHD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Advancing Real-World Evidence for Regulatory Decision-Making: Academic perspective
Olaf Klungel, FISPE
Utrecht University, Netherlands
Professor of Pharmacoepidemiologic Methods
Advancing Real-World Evidence for Regulatory Decision-Making: industry perspective
Gracy G Crane, MS
Roche, United Kingdom
Policy Lead
Advancing Real-World Evidence for Regulatory Decision-Making: FDA perspective
Representative Invited
FDA, United States
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