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

Session Chair(s)

Peter Richard Arlett, MD, FFPM, FRCP

Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

Anja Van Haren, MSC

Eudravigilance coordinator, Medicines Evaluation Board (MEB), Netherlands

Taking into account the requirements set out in pharmacovigilance legislation, this session will focus on the preparation for the use of the new data formatISO/ICH ICSR E2B(R3), for the simplified reporting to EudraVigilance, and for the implementation of the revised EudraVigilance Access Policy, which will lead to increased access to adverse reactions reports and industry responsibilities for signal detection.

Speaker(s)

Francois Domergue

EV Auditable Requirement Project Manager, Business Data and Analytics Department, European Medicines Agency, Netherlands

Presentation and Discussion of the EudraVigilance Change Management Plan

Sabine Brosch, PHARMD, PHD, MPHARM

Data Protection Officer, European Medicines Agency, Netherlands

Revision of the EudraVigilance Access Policy on Suspected Adverse Reactions – Direction of Travel

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