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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; Propose practical insights, informed by multi-stakeholder perspectives, for developing a framework of regulatory acceptability of RWE.
Speaker(s)
Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact
Alison Cave, PHD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
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