Third industry stakeholder platform: operation of European Union pharmacovigilance legislation
Date:
13/03/2015
Location:
European Medicines Agency, London, UK
The third 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 13 March 2015. Discussion at the meeting focused primarily on pharmacovigilance information systems and services (including Article 57 product database, Eudravigilance, medical literature monitoring and the periodic safety report (PSUR) repository), the introduction of pharmacovigilance fees, as well as a review of experience with PSUR and referrals procedures. The meeting provided a valuable opportunity to obtain practical feedback on the available systems, processes and guidelines. Updates on post-authorisation safety studies (PASS) management through EMA scientific advice and upcoming activities on risk management plan (template and GVP XVI addendum updates) were also presented by the regulators.
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Highlights from the EMA Industry Platform meeting on the Operation of EU pharmacovigilance legislation – 13 March 2015 (PDF/81.33 KB)
First published: 04/05/2015
Last updated: 04/05/2015
EMA/230906/2015 -
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Agenda - Third industry stakeholder platform on the operation of European Union pharmacovigilance legislation (PDF/80.68 KB)
First published: 17/03/2015
Last updated: 17/03/2015
EMA/56551/2015 -
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Participants list - Third industry stakeholder platform on the operation of European Union pharmacovigilance legislation (PDF/72.51 KB)
First published: 17/03/2015
Last updated: 17/03/2015
EMA/177559/2015 -
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Presentation - Pharmacovigilance information systems and services (Peter Arlett) (PDF/373.32 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Non imposed post authorisation safety studies (PASS) protocols (Jane Moseley) (PDF/198.22 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (Sabine Brosch) (PDF/378.95 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Periodic safety update single assessment (PSUSA) procedure EU reference dates (EURD) list and submission aspect (Menno Van Der Elst) (PDF/484.46 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Pharmacovigilance fees (Michael Lenihan) (PDF/159.82 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Periodic safety update single assessment (PSUSA) assessment aspects (Margarida Guimaraes) (PDF/403.82 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Guideline on good pharmacovigilance practices GVP module XVI addendum I - Educational materials (Margarida Guimaraes) (PDF/354.35 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Update on revision of risk management plan (RMP) guidance and on pilot of new RMP template (Michael Berntgen) (PDF/70.88 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Periodic safety update reports (PSUR) repository and the EU single assessment (Irene Rager) (PDF/132.29 KB)
First published: 17/03/2015
Last updated: 17/03/2015 -
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Presentation - Referrals update from the regulators (Almath Spooner and Tania Teixeira) (PDF/123.42 KB)
First published: 17/03/2015
Last updated: 17/03/2015