Fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation
EventCorporate
Date
- Friday, 12 June 2015, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
The fourth platform meeting with industry stakeholder associations on the implementation and operation of the European pharmacovigilance legislation took place at the European Medicines Agency (EMA) on 12 June 2015. Discussion focused primarily on pharmacovigilance information systems and services (including the Article 57 product database, the periodic safety update reports repository, Eudravigilance, medical literature monitoring and pharmacovigilance fees). The impact of pharmacovigilance systems was also discussed, followed by industry feedback on ongoing initiatives. Updates on risk management plan activities (RMP, good pharmacovigilance practices (GVP) Module V, RMP template updates, and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human subgroup on RMP for same active substances) and updates on GVP Module P-II and biological medicinal products were also presented. The agenda and presentations made by regulators are published on the EMA website.