EMA Releases Presentations, Videos from Pharmacovigilance Stakeholder Meeting
The European Medicines Agency (EMA) today (2 April) released video and presentations from its fourth stakeholder forum on the implementation of the new pharmacovigilance legislation.
The meeting was held 27 February 2012, and heard presentations from members of EMA, the European Commission, the Irish Medicines Board, the Finnish Medicines Agency and the Medicines and Healthcare products Regulatory Agency.
The presentations included:
- Welcome and introduction - June Raine - Medicines and Healthcare Products Regulatory Agency, UK (Video)
- Implementation of pharmacovigilance legislation: prioritisation of activities - Peter Arlett - Pharmacovigilance and Risk Management, European Medicines Agency (Video)
- EudraVigilance access policy - update - Sarah Weatherley - Communications and Media, EMA (Video)
- Pharmacovigilance and Risk Assessment Committee nomination - update on status - Sheila Kennedy - Regulatory, Procedural and Committee Support, EMA (Video)
- Transitional arrangements - Florian Schmidt - European Commission (Video)
- Implementation of Regulation 1235/2010, Article 57(2) - Sabine Brosch - Pharmacovigilance and Risk Management, EMA (Video)
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module I: Pharmacovigilance systems and their quality discussion - Suvi Loikkanen - Finnish Medicines Agency
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module II: Pharmacovigilance system master file - Joanna Harper - Medicines and Healthcare Products Regulatory Agency, UK
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module V: Risk management systems - Stella Blackburn - Pharmacovigilance and Risk Management, EMA (Video)
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module VI: Individual case safety reports - Gilles Touraille - Pharmacovigilance and Risk Management, EMA (Video)
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module VII: Periodic safety update reports - Almath Spooner - Irish Medicines Board (Video)
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module VIII: Post-authorisation safety studies - Xavier Kurz - Pharmacovigilance and Risk Management, EMA (Video)
- First wave of good pharmacovigilance practice modules - Discussion and feedback on module IX: Signal management - Agnieszka Szmigiel - Pharmacovigilance and Risk Management, EMA (Video)
- Conclusions - Peter Arlett - Pharmacovigilance and Risk Management, EMA (Video)
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