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

EventCorporate

Latvian is available via eTranslation, the European Commission's machine translation service.

Translate to Latvian | Important information about machine translation

Datums: Otrdiena, 20 Marts 2018, Visu dienu
Atrašanās vieta: 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)

Pirmo reizi publicēts: 07/05/2018 Pēdējo reizi atjaunināts: 07/05/2018

Agenda - Thirteenth industry stakeholder platform - operation of EU pharmacovigilance

Reference Number: EMA/117206/2018

English (EN) (127.03 KB - PDF)

Pirmo reizi publicēts: 14/03/2018 Pēdējo reizi atjaunināts: 14/03/2018

Presentation - PRAC Work Plan 2018 (J. Raine)

English (EN) (204.94 KB - PDF)

Pirmo reizi publicēts: 03/05/2018 Pēdējo reizi atjaunināts: 03/05/2018

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

English (EN) (370.05 KB - PDF)

Pirmo reizi publicēts: 03/05/2018 Pēdējo reizi atjaunināts: 03/05/2018

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

English (EN) (111.84 KB - PDF)

Pirmo reizi publicēts: 03/05/2018 Pēdējo reizi atjaunināts: 03/05/2018

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

English (EN) (943.49 KB - PDF)

Pirmo reizi publicēts: 03/05/2018 Pēdējo reizi atjaunināts: 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)

Pirmo reizi publicēts: 03/05/2018 Pēdējo reizi atjaunināts: 03/05/2018

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

English (EN) (461.55 KB - PDF)

Pirmo reizi publicēts: 03/05/2018 Pēdējo reizi atjaunināts: 03/05/2018