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)

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

Georgy Genov, MD

European Medicines Agency, Netherlands

Head of Pharmacovigilance Office

Industry Readiness for the New EudraVigilance

David John Lewis, PhD

Novartis Pharma Gmbh, Switzerland

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance

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