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International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
Session Chair(s)
Stephanie Choi, PhD
Director, US Global Regulatory and Scientific Policy (GRASP)
EMD Serono, United States
This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.
Learning Objective : Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Evaluate gaps in RWE harmonization needs
Speaker(s)
ICH Efforts in International RWE Harmonization
Representative Invited
FDA, United States
Emerging guidelines in RWE
Representative Invited
European Medicines Agency, Netherlands
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