DIA EUROPE 2019

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GVP Module V Risk Management Plan: Lessons Learned One Year after the Revision 2

Session Chair(s)

Francoise Sillan, MD

EU1 UK QPPV

Ipsen, France

Sabine Straus, MD, PhD, MSc

PRAC Chair, Staff Member

Medicines Evaluation Board (MEB), Netherlands

This session will provide an overview on Risk Management Plan preparation nearly two year after of the implementation of the revision 2 of module V and the updated RMP template. The lessons learned from that change and challenges will be presented and discussed by a panel of experts from industry and regulatory authorities.

Learning Objective : This session will provide the attendants with a brief overview of lessons learnt as regards the PhV legislation implementation, especially from generics sector perspective. With special focus on reoccurring challenges for generics sector: availability/transparency of originator data, work-sharing procedure challenges, lack of streamlined processes & duplication of efforts.

Speaker(s)

Result of the EFPIA Survey on the RMP Implementation

Jane Feron

AstraZeneca UK Ltd, United Kingdom

Risk Management Director

Time to Reflect and Build on Experience: Generics Sector View

Susana Almeida, PhD

Medicines for Europe, Belgium

Clinical Development and Safety Director

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