13th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Date:
  dinsdag, 20 maart 2018, Hele dag
• Locatie:
  European Medicines Agency, Amsterdam, the Netherlands

The thirteenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system takes place at the European Medicines Agency on 20 March 2018. Discussions focus on the new EudraVigilance system and the pilot of MAHs EudraVigilance signal detection.

Documents

Highlights from the 13th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 20 March 2018

Reference Number: EMA/181781/2018

Agenda - Thirteenth industry stakeholder platform - operation of EU pharmacovigilance

Reference Number: EMA/117206/2018

Presentation - PRAC Work Plan 2018 (J. Raine)

Presentation - Pilot of MAH signal detection in EudraVigilance (J. Durand, EMA)

Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (P. Bahri, EMA)

Presentation - New EudraVigilance system – Progress update (S. Brosch, F. Domergue)

Presentation - GVP paediatrics highlights. Product- or population-specific considerations IV: Paediatric population (R. De Lisa, EMA)

Presentation - UK’s withdrawal from the EU - preparedness activities update (T. Humphreys, EMA)