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

• Date:
  Monday, 27 February 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

Reference Number: EMA/53186/2012

List of participants - Fourth stakeholders forum on the implementation of the new pharmacovigilance legislation

Reference Number: EMA/100161/2012 Rev.1

Presentation - Implementation of the new pharmacovigilance legislation - 2012 implementation plan

Presentation - Implementation of the EudraVigilance access policy for centrally authorised products - Phase 1

Presentation - Nomination of members to the Pharmacovigilance Risk Assessment Committee

Presentation - Transitional arrangements

Presentation - Implementation of Regulation 1235/2010, Article 57(2)

Presentation - Guideline on good pharmacovigilance practices (GVP) - Module I: Pharmacovigilance systems and their quality systems

Presentation - Module II - Pharmacovigilance system master file

Presentation - Good pharmacovigilance practice risk management systems

Presentation - Good pharmacovigilance practice module VI

Presentation: Good pharmacovigilance practice module VII – Periodic safety update report

Presentation - Good pharmacovigilance practice module VIII - Post-authorisation safety studies

Presentation - Good pharmacovigilance practice module IX: Signal management

Multimedia