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Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?
Session Chair(s)
Gracy G Crane, MS
Policy Lead
Roche, United Kingdom
This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regions
Learning Objective : Explain the current guidance and reflection papers on the use of external controls from leading regulatory agencies (FDA, PMDA, MHRA) and discuss recent progress within the EU on this topic; Analyze the key similarities and differences in regulatory recommendations for study design, and describe the rationale for greater alignments across agencies.
Speaker(s)
Panelist
Representative Invited
FDA, United States
Denise Umuhire, MBA, MSC
European Medicines Agency, Netherlands
Pharmacoepidemiologist and Real-World Evidence Specialist
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