EudraVigilance information day
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Dato
- Tirsdag, 19 september 2017, Hele dagen
Lokation
- European Medicines Agency, Amsterdam, the Netherlands
EudraVigilance information day provides a forum to discuss the final steps in preparation of the simplified adverse reaction reporting, the new signal management for marketing authorisation holders in the European Economic Area (EEA) as well as the initial testing experience by stakeholders. More specifically, the focus of this information day will be on the EudraVigilance go-live planning and the preparations and actions required by national competent authorities in the EEA, marketing authorisation holders and sponsors of clinical trials. The information day will also serve as a platform to experts to share their testing experience based on the use of the new EudraVigilance XCOMP (test) environment, which was released on 26 June 2017 and to raise specific process related and technical questions.