Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation

  • Email
  • Help

Details

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

Media Videos