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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 1 continued: Adverse Reaction Reporting and Analysis, EudraVigilance System Changes to Come

Speaker(s)

Georgy Genov, MD

Georgy Genov, MD

Head of Pharmacovigilance Office, European Medicines Agency, Netherlands

Signal Management at the EMA, Planned Revision of GVP Module IX (Signal Management) and the Scientific Guideline on Signal Detection

David John Lewis, PHD

David John Lewis, PHD

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

Industry Readiness for the New EudraVigilance

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