Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation

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TitleSixth stakeholder forum on the implementation of the new pharmacovigilance legislation
Date08/11/2012 - 08/11/2012
LocationEuropean Medicines Agency, London, UK
SummaryThis is the sixth in the series of stakeholder forums on the implementation of the new pharmacovigilance legislation. The objectives of this meeting are to present an update on the prioritised implementation and future planning, share first experiences on activities undertaken at European Medicines Agency level and get immediate feedback from stakeholders on the overall implementation process. Registration closed.

All documents

Name Language First published Last updated
Agenda – Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation (English only) 2012-11-06 2012-12-07
Presentation - Session of first experiences: black symbol and product information (Alexios Skarlatos) (English only) 2012-12-07  
Presentation - Functioning of the PRAC (Almath Spooner) (English only) 2012-12-07  
Presentation - European Medicines Agency / Heads of Medicines Agencies questions and answers – practical transitional measures - November update (Christelle Bouygues) (English only) 2012-12-07  
Presentation - Patient organisations' considerations (David Haerry) (English only) 2012-12-07  
Presentation - Good pharmacovigilance practices module IV: Pharmacovigilance audit (Edit Weidlich) (English only) 2012-12-07  
Presentation - Implementation of the new pharmacovigilance legislation: Key achievements and status of prioritised implementation (Franck Diafouka) (English only) 2012-12-07  
Presentation - Emerging safety issues (Georgy Genov) (English only) 2012-12-07  
Presentation - Update on pharmacovigilance legislation (Helen Lee) (English only) 2012-12-07  
Presentation - Good pharmacovigilance practices module XV (Jane Ahlqvist Rastad, Juan Garcia Burgos) (English only) 2012-12-07  
Presentation - First experiences: PRAC transparency (June Raine) (English only) 2012-12-07  
Presentation - Reflections and experiences of healthcare professionals on the implementation of the directive so far (Jurate Svarcaite) (English only) 2012-12-07  
Presentation - Publication of the list of Union reference dates and frequency of periodic safety update reports (European Union reference dates list) and the list of active substances subject to worksharing for signal management (Kelly Brown) (English only) 2012-12-07  
Presentation - New European Union pharmacovigilance legislation: Early industry experience, challenges for implementation and some proposals (Laurent Auclert) (English only) 2012-12-07  
Presentation - Good pharmacovigilance practices module X - additional monitoring of medicines (Mick Foy) (English only) 2012-12-07  
Presentation - Forward (Peter Arlett) (English only) 2012-12-07  
Presentation - Module III pharmacovigilance inspections (Suvi Loikkanen) (English only) 2012-12-07  
Presentation - Signal management (Sabine Straus) (English only) 2012-12-07  
Presentation - Post-authorisation safety studies and the European Union post-authorisation-safety-study register (Xavier Kurz) (English only) 2012-12-07  

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