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Thursday, February 7 • 09:15 - 10:15
#S0305: GVP Module V Risk Management Plan: Lessons Learned One Year after the Revision 2

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Component Type: Session

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.


Francoise Dumas-Sillan
Sabine Straus, MD, PhD, MSc


Result of the EFPIA Survey on the RMP Implementation
Jane Feron

Time to Reflect and Build on Experience: Generics Sector View 
Susana Almeida, PhD

avatar for Francoise Dumas-Sillan

Francoise Dumas-Sillan

EU QPPV, Pfizer Italy
Françoise is a medical doctor as background, working in Pharmacovigilance for more than 20 years in big Pharmaceutical companies with different managerial roles (Sanofi, now Pfizer), exposure to international activities and interactions with Health Authorities, and has been in charge... Read More →
avatar for Susana Almeida

Susana Almeida

Clinical Development and Safety Director, Medicines for Europe
Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe. Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. She has worked in clinical development in Europe and in North... Read More →
avatar for Sabine Straus

Sabine Straus

PRAC Chair, Staff Member, Medicines Evaluation Board (MEB)
Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle... Read More →
avatar for Jane Feron

Jane Feron

Risk Management Director, AstraZeneca UK Ltd
Jane Feron BSc (Hons) has spent most of here working life in the pharmaceutical industry. After working in Clinical Research for nearly 10 years, she joined the PV department at AstraZeneca. She worked in safety surveillance before becoming the process owner for Risk Management and... Read More →

Thursday February 7, 2019 09:15 - 10:15 CET
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  03 Pharmacovigilance, Session
  • Featured Topics Pharmacovigilance
  • Tags Session