European Medicines Agency workshop for micro, small and medium-sized enterprises (SMEs) – Focus on pharmacovigilance
Date:
19/04/2012
Location:
European Medicines Agency, London, UK
As regulators and pharmaceutical companies are gearing themselves up for the introduction of the new pharmacovigilance legislation in July 2012, this year's training workshop aims to provide an update on pharmacovigilance while also getting to grips with key changes of the new legislation and on how to prepare for its implementation. The sessions are being presented by representatives of the Agency, the Pharmacovigilance Working Party and national competent authorities and the questions and answers moderated by SME representatives. There is no registration fee for this event.
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Agenda - European Medicines Agency workshop for micro, small and medium-sized enterprises (SMEs) - Focus on pharmacovigilance (PDF/74.99 KB)
Adopted
First published: 24/02/2012
Last updated: 03/05/2012
EMA/49479/2012 -
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Presentation - Focus on pharmacovigilance: Introduction (PDF/311.39 KB)
First published: 03/05/2012
Last updated: 03/05/2012 -
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Presentation - Overview of the new pharmacovigilance legislation (PDF/382.76 KB)
First published: 03/05/2012
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Presentation - Quality systems for pharmacovigilance (PDF/150.13 KB)
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Presentation - Good pharmacovigilance practices module II: Pharmacovigilance system master file (PDF/56.51 KB)
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Presentation - Perspective on the implementation of a pharmacovigilance system (PDF/1.36 MB)
First published: 03/05/2012
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Presentation - Management and reporting of adverse reactions to medicinal products: Good pharmacovigilance practice module VI (PDF/141.92 KB)
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Presentation - Good pharmacovigilance practice module IX: Signal management (PDF/504.02 KB)
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Presentation - Periodic safety update reports under the new European Union pharmacovigilance legislation (PDF/540.25 KB)
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Presentation - Good pharmacovigilance practice risk-management systems (PDF/255.5 KB)
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Presentation - Post-authorisation safety studies (PDF/125.73 KB)
First published: 03/05/2012
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Presentation - International standards (PDF/391.84 KB)
First published: 03/05/2012
Last updated: 03/05/2012 -
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Presentation - Implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 (PDF/731.49 KB)
First published: 03/05/2012
Last updated: 03/05/2012