Third industry stakeholder platform: operation of European Union pharmacovigilance legislation

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TitleThird industry stakeholder platform: operation of European Union pharmacovigilance legislation
Date13/03/2015 - 13/03/2015
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Highlights from the EMA Industry Platform meeting on the Operation of EU pharmacovigilance legislation – 13 March 2015 (English only) 2015-05-04  
Agenda - Third industry stakeholder platform on the operation of European Union pharmacovigilance legislation (English only) 2015-03-17  
Participants list - Third industry stakeholder platform on the operation of European Union pharmacovigilance legislation (English only) 2015-03-17  
Presentation - Pharmacovigilance information systems and services (Peter Arlett) (English only) 2015-03-17  
Presentation - Non imposed post authorisation safety studies (PASS) protocols (Jane Moseley) (English only) 2015-03-17  
Presentation - Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (Sabine Brosch) (English only) 2015-03-17  
Presentation - Periodic safety update single assessment (PSUSA) procedure EU reference dates (EURD) list and submission aspect (Menno Van Der Elst) (English only) 2015-03-17  
Presentation - Pharmacovigilance fees (Michael Lenihan) (English only) 2015-03-17  
Presentation - Periodic safety update single assessment (PSUSA) assessment aspects (Margarida Guimaraes) (English only) 2015-03-17  
Presentation - Guideline on good pharmacovigilance practices GVP module XVI addendum I - Educational materials (Margarida Guimaraes) (English only) 2015-03-17  
Presentation - Update on revision of risk management plan (RMP) guidance and on pilot of new RMP template (Michael Berntgen) (English only) 2015-03-17  
Presentation - Periodic safety update reports (PSUR) repository and the EU single assessment (Irene Rager) (English only) 2015-03-17  
Presentation - Referrals update from the regulators (Almath Spooner and Tania Teixeira) (English only) 2015-03-17  

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