14th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Date:
  Friday, 28 September 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This platform meeting with industry stakeholder associations will cover:

• new EudraVigilance functionalities;
• new risk management plan guidance and template;
• the pilot of Eudravigilance signal detection by marketing authorisation holders;
• updates from the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh);
• emerging scientific and technological approaches to collecting and managing pharmacovigilance data.

Documents

Agenda – 14th Industry Stakeholder Platform – Operation of EU Pharmacovigilance

Reference Number: EMA/496794/2018

Presentation – Feedback on EudraVigilance & new functionalities (Anja van Haren, Sabine Brosch, F. Domergue)

Presentation – Issues and update from the CMDh (Kora Doorduyn-van der Stoep)

Presentation – EudraVigilance registration updates (Oana Agheorghiesei)

Presentation – UK’s withdrawal from the EU: Preparedness activities update (Marie-Helene Pinheiro)