Fourth stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation

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TitleFourth stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation
Date27/02/2012 - 27/02/2012
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - Fourth stakeholder forum on the implementation of the new 2010 pharmacovigilance legislation (English only) 2012-02-23 2012-02-29
List of participants - Fourth stakeholders forum on the implementation of the new pharmacovigilance legislation (English only) 2012-02-29 2012-03-05
Presentation - Implementation of the new pharmacovigilance legislation - 2012 implementation plan (English only) 2012-02-29  
Presentation - Implementation of the EudraVigilance access policy for centrally authorised products - Phase 1 (English only) 2012-02-29  
Presentation - Nomination of members to the Pharmacovigilance Risk Assessment Committee (English only) 2012-02-29  
Presentation - Transitional arrangements (English only) 2012-02-29  
Presentation - Implementation of Regulation 1235/2010, Article 57(2) (English only) 2012-02-29  
Presentation - Guideline on good pharmacovigilance practices (GVP) - Module I: Pharmacovigilance systems and their quality systems (English only) 2012-02-29  
Presentation - Module II - Pharmacovigilance system master file (English only) 2012-02-29  
Presentation - Good pharmacovigilance practice risk management systems (English only) 2012-02-29  
Presentation - Good pharmacovigilance practice module VI (English only) 2012-02-29  
Presentation: Good pharmacovigilance practice module VII – Periodic safety update report (English only) 2012-02-29  
Presentation - Good pharmacovigilance practice module VIII - Post-authorisation safety studies (English only) 2012-02-29  
Presentation - Good pharmacovigilance practice module IX: Signal management (English only) 2012-02-29  

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