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Session 5: Update of GVP Module V – Improving the Risk Management Systems
Session Chair(s)
Martin Huber, MPH, MPharm
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
Federal Institute for Drugs and Medical Devices (BfArM), Germany
EMA has recently published an update to the GVP module V, which guides risk management practices. This session will welcome regulators from EMA, national authority and PRAC as well as industry to discuss their recommendations for implementation of the updates. Focus of the session will be on: - Major changes in GVP Module V - Amended definitions: important identified risks and important potential risks - Interpretation of the new requirements - Implications for regulators and industry
Speaker(s)
GVP V Update – What We Would Like to Achieve
Martin Huber, MPH, MPharm
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
GVP V and RMP Template Rev 2 – What Is New? Practical Advice for Implementation and Transition
Emil Andrei Cochino, MD, MHS
European Medicines Agency, Netherlands
Scientific Senior Specialist (Risk Management)
Major Revision of the GVP Module V from the Industry Perspective
Zuzana Vinterova, PhD
PrimeVigilance s.r.o., Czech Republic
Strategic Advisor, Medical Writing