Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation

• Date:
  Thursday, 8 November 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This 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.

Documents

Agenda – Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation

Reference Number: EMA/652724/2012

Presentation - Session of first experiences: black symbol and product information (Alexios Skarlatos)

Presentation - Functioning of the PRAC (Almath Spooner)

Presentation - European Medicines Agency / Heads of Medicines Agencies questions and answers – practical transitional measures - November update (Christelle Bouygues)

Presentation - Patient organisations' considerations (David Haerry)

Presentation - Good pharmacovigilance practices module IV: Pharmacovigilance audit (Edit Weidlich)

Presentation - Implementation of the new pharmacovigilance legislation: Key achievements and status of prioritised implementation (Franck Diafouka)

Presentation - Emerging safety issues (Georgy Genov)

Presentation - Update on pharmacovigilance legislation (Helen Lee)

Presentation - Good pharmacovigilance practices module XV (Jane Ahlqvist Rastad, Juan Garcia Burgos)

Presentation - First experiences: PRAC transparency (June Raine)

Presentation - Reflections and experiences of healthcare professionals on the implementation of the directive so far (Jurate Svarcaite)

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 ma...

Presentation - New European Union pharmacovigilance legislation: Early industry experience, challenges for implementation and some proposals (Laurent Auclert)

Presentation - Good pharmacovigilance practices module X - additional monitoring of medicines (Mick Foy)

Presentation - Forward (Peter Arlett)

Presentation - Module III pharmacovigilance inspections (Suvi Loikkanen)

Presentation - Signal management (Sabine Straus)

Presentation - Post-authorisation safety studies and the European Union post-authorisation-safety-study register (Xavier Kurz)