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

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance

Novartis Pharma Gmbh, Switzerland

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)

Experience with the use of the Repository

Steven J. Blumenthal, MSc

Merck & Co., Inc., United States

Director, Global Safety

PSUR Repository – Status Update and Next Steps

Ana Zanoletty Perez

European Medicines Agency, Netherlands

Head of Clinical Trials Transformation Workstream

Panel Discussion

David John Lewis, PhD

Novartis Pharma Gmbh, Switzerland

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance

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EMA Information Day on Services and Systems in Pharmacovigilance

Session 2: PSUR Repository – Achievements and Next Steps

Session Chair(s)

David John Lewis, PhD

Irene Rager

Speaker(s)

Experience with the use of the Repository

PSUR Repository – Status Update and Next Steps

Panel Discussion

Be informed and stay engaged.