Fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation
Date:
12/06/2015
Location:
European Medicines Agency, London, UK
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.
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Highlights from the fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation (PDF/89.03 KB)
First published: 14/07/2015
Last updated: 14/07/2015
EMA/400212/2015 -
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Agenda - Fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation (PDF/117.82 KB)
First published: 25/06/2015
Last updated: 25/06/2015
EMA/402820/2015 -
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Participants list - Fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation (PDF/83.63 KB)
First published: 25/06/2015
Last updated: 25/06/2015
EMA/402803/2015 -
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Presentation - Update on pharmacovigilance systems and services (Peter Arlett) (PDF/595.65 KB)
First published: 25/06/2015
Last updated: 25/06/2015 -
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Presentation - Impact of pharmacovigilance systems (Jacoline Bouvy) (PDF/288.36 KB)
First published: 25/06/2015
Last updated: 25/06/2015 -
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Presentation - GVP V update (Corinne de Vries) (PDF/313.77 KB)
First published: 25/06/2015
Last updated: 25/06/2015 -
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Presentation - Good pharmacovigilance practices (GVP): module P-II biological medicinal products (Xavier Kurz) (PDF/137.26 KB)
First published: 25/06/2015
Last updated: 25/06/2015 -
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Presentation - CMDh subgroup on RMP, for same active substances CMDh RMP webpage/cover note /list of safety concerns per approved Risk Management Plan (RMP) of active substances per product (Kora Doorduyn-van der Stoep) (PDF/73.17 KB)
First published: 25/06/2015
Last updated: 25/06/2015 -
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Presentation - RMP template (Caroline Voltz-Girolt) (PDF/97.25 KB)
First published: 25/06/2015
Last updated: 25/06/2015