Fourth stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation
Date:
27/02/2012
Location:
European Medicines Agency, London, UK
The objectives of this fourth meeting are to present an update on the implementation process, transitional arrangements and discuss the good pharmacovigilance practices (GVP) modules that have been released for public consultation. Industry, patient, consumer and healthcare professional representatives as well as representatives from the European Commission and national medicines regulatory authorities will attend. Registration by invitation only.
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Agenda - Fourth stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation (PDF/113.29 KB)
First published: 23/02/2012
Last updated: 29/02/2012
EMA/53186/2012 -
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List of participants - Fourth stakeholders forum on the implementation of the new pharmacovigilance legislation (PDF/121.72 KB)
First published: 29/02/2012
Last updated: 05/03/2012
EMA/100161/2012 Rev.1 -
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Presentation - Implementation of the new pharmacovigilance legislation - 2012 implementation plan (PDF/577.08 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Implementation of the EudraVigilance access policy for centrally authorised products - Phase 1 (PDF/257.68 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Nomination of members to the Pharmacovigilance Risk Assessment Committee (PDF/506.68 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Transitional arrangements (PDF/909.67 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Implementation of Regulation 1235/2010, Article 57(2) (PDF/580.81 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Guideline on good pharmacovigilance practices (GVP) - Module I: Pharmacovigilance systems and their quality systems (PDF/285.33 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Module II - Pharmacovigilance system master file (PDF/534.74 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Good pharmacovigilance practice risk management systems (PDF/779.19 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Good pharmacovigilance practice module VI (PDF/406.27 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation: Good pharmacovigilance practice module VII – Periodic safety update report (PDF/635.16 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Good pharmacovigilance practice module VIII - Post-authorisation safety studies (PDF/444.83 KB)
First published: 29/02/2012
Last updated: 29/02/2012 -
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Presentation - Good pharmacovigilance practice module IX: Signal management (PDF/501.45 KB)
First published: 29/02/2012
Last updated: 29/02/2012