14th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
Date:
28/09/2018
Location:
European Medicines Agency, London, UK
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.
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Agenda – 14th Industry Stakeholder Platform – Operation of EU Pharmacovigilance (PDF/162.5 KB)
First published: 02/10/2018
EMA/496794/2018 -
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Presentation – Feedback on EudraVigilance & new functionalities (Anja van Haren, Sabine Brosch, F. Domergue) (PDF/750 KB)
First published: 12/10/2018 -
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Presentation – Issues and update from the CMDh (Kora Doorduyn-van der Stoep) (PDF/202.45 KB)
First published: 12/10/2018 -
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Presentation – EudraVigilance registration updates (Oana Agheorghiesei) (PDF/203.98 KB)
First published: 12/10/2018 -
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Presentation – UK’s withdrawal from the EU: Preparedness activities update (Marie-Helene Pinheiro) (PDF/1.29 MB)
First published: 12/10/2018