5th industry stakeholder platform - Operation of EU pharmacovigilance legislation

• Date:
  Tuesday, 15 September 2015
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The fifth platform meeting with industry stakeholder associations on the implementation and operation of the European pharmacovigilance legislation took place at the EMA on 15 September 2015. Discussion at the meeting focused primarily on Pharmacovigilance systems and services (including Article 57 product database, Eudravigilance, medical literature monitoring and PSUR), as well as risk management summary publication. The agenda and presentations made by the regulators at the meeting are published on the EMA website.

Documents

Agenda – 5th industry stakeholder platform - Operation of EU pharmacovigilance legislation

Reference Number: EMA/549299/2015

Participants list from the 5th industry stakeholder platform - Operation of EU pharmacovigilance legislation

Reference Number: EMA/47443/2016

Presentation - Medical literature monitoring (Tom Paternoster-Howe)

Presentation - Update on Pharmacovigilance systems and services (Peter Arlett)

Presentation - Publication of risk management plan (RMP) summaries (Juan Garcia Burgos and Caroline Voltz)

Presentation - Risk management summary publication - Review of experience – update CMDh activities since 12 June 2015 (Kora Doorduyn-van der Stoep)

Highlights from the 5th EMA Industry platform meeting on the operation of EU pharmacovigilance legislation

Reference Number: EMA/609257/2015