Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union

• Date:
  fredag, 3 februari 2017, Hela dagen
• Plats:
  European Medicines Agency, Amsterdam, the Netherlands

The tenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will discuss good pharmacovigilance practices, periodic safety update reports and registries.

Documents

Minutes - Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union

Reference Number: EMA/80558/20177

Agenda - Tenth industry stakeholder platform on the operation of EU pharmacovigilance

Reference Number: EMA/42931/2016

Presentation - Progress update: MLM and EV auditable requirements project (Georgy Genov)

Presentation - 2017 PRAC work plan (June Raine)

Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (Priya Bahri)

Presentation - EU PASS/PAES requirements for disclosure (Thomas Goedecke)

Presentation - Consultation on the explanatory note to GVP Module VII (CBG MEB)

Presentation - PSUR roadmap (Irene Rager)

Presentation - MAH compliance with PRAC signal recommendations for PI update of CAPs (Aniello Santoro)

Presentation - Registries: Recommendations from the registries workshop (Xavier Kurz)