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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)
Industry Approaches - A Pre-Authorisation Framework to Support Earlier and More Robust Generation of Data in Individuals of Childbearing Potential and in Pregnancy
Charlotte L Root
Director Safety & Pharmacovigilance, Viiv Healthcare, United Kingdom
Annemiek De Ruiter
VP & Head Global Medical Sciences, Viiv Healthcare, United Kingdom
Pregnancy Outcomes Intensive Monitoring (PRIM) - a Post-authorization study design utilizing enhanced PV data.
Anna Beckmeyer-Borowko, PhD
Associate Director Epidemiologist, Novartis Pharma, Switzerland
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