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Industry approaches in pre- and post-authorisation data generation
Session Chair(s)
Robert Massouh, MPHARM, RPH
Head of Safety (PV) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom
Speaker(s)
Representative Invited
,
Industry Approaches - A pre-authorisation framework to support earlier and more Robust generation of data in individuals of childbearing potential
Anna Beckmeyer-Borowko
Associate Director Epidemiologist, Novartis Pharma, Switzerland
Pregnancy Outcomes Intensive Monitoring (PRIM) - a Post-authorization study design utilizing enhanced PV data.
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