Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation
Date:
08/11/2012
Location:
European Medicines Agency, London, UK
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.
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Agenda – Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation (PDF/153.17 KB)
First published: 06/11/2012
Last updated: 07/12/2012
EMA/652724/2012 -
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Presentation - Session of first experiences: black symbol and product information (Alexios Skarlatos) (PDF/332.66 KB)
First published: 07/12/2012
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Presentation - Functioning of the PRAC (Almath Spooner) (PDF/621.76 KB)
First published: 07/12/2012
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Presentation - European Medicines Agency / Heads of Medicines Agencies questions and answers – practical transitional measures - November update (Christelle Bouygues) (PDF/303.67 KB)
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Presentation - Patient organisations' considerations (David Haerry) (PDF/729.03 KB)
First published: 07/12/2012
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Presentation - Good pharmacovigilance practices module IV: Pharmacovigilance audit (Edit Weidlich) (PDF/438.36 KB)
First published: 07/12/2012
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Presentation - Implementation of the new pharmacovigilance legislation: Key achievements and status of prioritised implementation (Franck Diafouka) (PDF/2.82 MB)
First published: 07/12/2012
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Presentation - Emerging safety issues (Georgy Genov) (PDF/239.24 KB)
First published: 07/12/2012
Last updated: 07/12/2012 -
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Presentation - Update on pharmacovigilance legislation (Helen Lee) (PDF/256.69 KB)
First published: 07/12/2012
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Presentation - Good pharmacovigilance practices module XV (Jane Ahlqvist Rastad, Juan Garcia Burgos) (PDF/193.43 KB)
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Presentation - First experiences: PRAC transparency (June Raine) (PDF/1.57 MB)
First published: 07/12/2012
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Presentation - Reflections and experiences of healthcare professionals on the implementation of the directive so far (Jurate Svarcaite) (PDF/1.24 MB)
First published: 07/12/2012
Last updated: 07/12/2012 -
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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... (PDF/516.38 KB)
First published: 07/12/2012
Last updated: 07/12/2012 -
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Presentation - New European Union pharmacovigilance legislation: Early industry experience, challenges for implementation and some proposals (Laurent Auclert) (PDF/213.77 KB)
First published: 07/12/2012
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Presentation - Good pharmacovigilance practices module X - additional monitoring of medicines (Mick Foy) (PDF/285.66 KB)
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Presentation - Forward (Peter Arlett) (PDF/687.91 KB)
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Presentation - Module III pharmacovigilance inspections (Suvi Loikkanen) (PDF/457.4 KB)
First published: 07/12/2012
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Presentation - Signal management (Sabine Straus) (PDF/3 MB)
First published: 07/12/2012
Last updated: 07/12/2012 -
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Presentation - Post-authorisation safety studies and the European Union post-authorisation-safety-study register (Xavier Kurz) (PDF/242.44 KB)
First published: 07/12/2012
Last updated: 07/12/2012