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European Medicines Agency

Dec 07, 2015 8:00 AM - Dec 07, 2015 5:00 PM

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

EMA Information Day on Services and Systems in Pharmacovigilance

This event will provide marketing-authorisation holders with information on the development of the enhanced systems, helping them prepare for the business change to come.

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Session 2: PSUR Repository – Achievements and Next Steps

Session Chair(s)

David John Lewis, PHD

David John Lewis, PHD

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance, Novartis Pharma Gmbh, Switzerland

Irene Rager

Irene Rager

Head of Service E, Procedure Management Department, European Medicines Agency, Netherlands

This session will focus on the latest PSUR Repository achievements and next steps towards the simplification of PSUR submissions benefiting pharmaceutical industry and NCAs taking into account that the Repository will be mandatory on 13 June 2016.

Speaker(s)

Steven J. Blumenthal, MSC

Steven J. Blumenthal, MSC

Director, Global Safety, Merck & Co., Inc., United States

Experience with the use of the Repository

Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation Workstream, European Medicines Agency, Netherlands

PSUR Repository – Status Update and Next Steps

David John Lewis, PHD

David John Lewis, PHD

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance, Novartis Pharma Gmbh, Switzerland

Panel Discussion

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