Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation
Date:
12/01/2015
Location:
European Medicines Agency, London, UK
This meeting focused primarily on experience with risk-management plans (RMP) and post-authorisation safety studies (PASS), with regulators presenting an update on recent developments and stakeholders providing valuable practical feedback on the available guidance and templates. An update on the development of a scientific and regulatory guideline for post-authorisation efficacy studies (PAES) was also provided. Registration by invitation only. Registration closed.
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Agenda - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation (PDF/75.5 KB)
Adopted
First published: 12/03/2015
Last updated: 12/03/2015
EMA/654663/2014 -
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Highlights - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation (PDF/76.8 KB)
First published: 12/03/2015
Last updated: 12/03/2015
EMA/38167/2015 -
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Participants list - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation (PDF/76.9 KB)
First published: 12/03/2015
Last updated: 12/03/2015
EMA/91293/2015 -
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Presentation - Guidance on post-authorisation efficacy studies (Jane Moseley) (PDF/123.33 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - Post-authorisation safety studies (PASS) (Irene Rager) (PDF/89.97 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - Periodic safety update report (PSUR) repository (Irene Rager) (PDF/177.9 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - Questions and answers on off-label use ( Sabine Brosch and Anja Haren) (PDF/115.11 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - Risk-management planning (Luis Prieto) (PDF/71.82 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - Strategy and pilot phase for patient registries (Xavier Kurz) (PDF/130.46 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP): Facilitating the conduct of post-authorisation study (PAS) (Henry Fitt) (PDF/284.77 KB)
First published: 12/03/2015
Last updated: 12/03/2015 -
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Presentation - Update on development of pharmacovigilance information systems (Peter Arlett) (PDF/284.33 KB)
First published: 12/03/2015
Last updated: 12/03/2015