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

EventCorporate

Date: Tuesday, 20 March 2018
Location: 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

English (EN) (91.52 KB - PDF)

First published: 07/05/2018Last updated: 07/05/2018

Agenda - Thirteenth industry stakeholder platform - operation of EU pharmacovigilance

Reference Number: EMA/117206/2018

English (EN) (127.03 KB - PDF)

First published: 14/03/2018Last updated: 14/03/2018

Presentation - PRAC Work Plan 2018 (J. Raine)

English (EN) (204.94 KB - PDF)

First published: 03/05/2018Last updated: 03/05/2018

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

English (EN) (370.05 KB - PDF)

First published: 03/05/2018Last updated: 03/05/2018

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

English (EN) (111.84 KB - PDF)

First published: 03/05/2018Last updated: 03/05/2018

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

English (EN) (943.49 KB - PDF)

First published: 03/05/2018Last updated: 03/05/2018

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

English (EN) (293.2 KB - PDF)

First published: 03/05/2018Last updated: 03/05/2018

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

English (EN) (461.55 KB - PDF)

First published: 03/05/2018Last updated: 03/05/2018