EMA Risk Management Information Day

This in-person information day will provide an overview of key developments in EU pharmacovigilance guidance related to the safe use of medicines during pregnancy and breastfeeding as well as updates in GVP Module V Risk Management Plans and GVP Module VIII Post authorisation safety studies (PASS).

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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)

Anna Beckmeyer-Borowko, PhD

Associate Director Epidemiologist, Novartis Pharma, Switzerland

Pregnancy Outcomes Intensive Monitoring (PRIM) - a Post-authorization study design utilizing enhanced PV data.

Charlotte L Root

Director Safety & Pharmacovigilance, Viiv Healthcare, United Kingdom

Industry Approaches - A Pre-Authorisation Framework to Support Earlier and More Robust Generation of Data in Individuals of Childbearing Potential and in Pregnancy

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