6th industry stakeholder platform - Operation of EU pharmacovigilance legislation

• Date:
  Friday, 18 December 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The sixth platform meeting with industry stakeholder associations on the implementation and operation of the European pharmacovigilance legislation took place at the EMA on 18 December 2015. Discussion at the meeting focused primarily on PSURs, medication errors, GVO on post-authorisation safety studies as well as Eudravigilance. The agenda and presentations made by the regulators at the meeting are published on the EMA website.

Documents

Agenda – 6th industry stakeholder platform - operation of EU pharmacovigilance legislation

Reference Number: EMA/727477/2015

Participants list – 6th industry stakeholder platform - operation of EU pharmacovigilance legislation

Reference Number: EMA/48691/2016

Presentation - Good practice guide on medication errors – Highlights and EU regulatory initiatives (Thomas Goedecke)

Presentation - Roadmap to periodic safety update reports (PSUR) (Irene Rager, Menno van der Elst, Kora Doorduyn van der Stoep)

Presentation - Signal Management in the EU and future extended access to EudraVigilance for industry (Georgy Genov)

Presentation - EudraVigilance: Preparing for change (Francois Domergue)

Presentation - Information updates (Peter Arlett)

Highlights from the 6th EMA Industry platform meeting on the operation of EU pharmacovigilance legislation – 18 December 2015

Reference Number: EMA/858235/2015