Seventh industry stakeholder platform: operation of European Union pharmacovigilance legislation

• Date:
  Mandag, 4 april 2016, Hele dagen
• Placering:
  European Medicines Agency, Amsterdam, the Netherlands

The seventh platform meeting with industry stakeholder associations on the implementation and operation of the European Pharmacovigilance Legislation will take place at the European Medicines Agency (EMA) on 4 April 2016. Discussion at the meeting will include a roadmap for periodic safety update reports (PSURs), scientific advice for post-authorisation studies and signal management. The agenda of the meeting is published on the EMA website.

Documents

Highlights from the 7th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 4 April 2016

Reference Number: EMA/241387/2016

Agenda - Seventh industry stakeholder platform: operation of European Union pharmacovigilance legislation

Reference Number: EMA/179833/2016

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

Presentation - Update on GVP Module P.II. Biologicals (Xavier Kurz, Sabine Brosch)

Presentation - EU Risk Management Plans: Update of the GVP Module V (Emil Cochino)

Presentation - PRAC interaction with SAWP (Anna Tavridou)

Presentation - Update on preparation for Signal Management (Georgy Genov)

Presentation - Collecting and reporting information on off-label use (Gilles Touraille, Sabine Brosch)

Presentation - EU network pharmacovigilance governance (Peter Arlett)

Presentation - PSUR repository (Ana Zanoletty)

Presentation - Update on the SPUR and PSUSA roadmap (Ana Zanoletty)