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

• Date:
  donderdag, 20 oktober 2011, Hele dag
• Locatie:
  European Medicines Agency, Amsterdam, the Netherlands

The objectives of this third meeting are to present an update on the implementation process, share the orientations related to the European Medicines Agency and Member States planning and prioritisation for the implementation, and continue to obtain relevant feedback from a range of topics particularly relevant to stakeholders.

Documents

Agenda - Third stakeholders forum on the implementation of the new pharmacovigilance legislation

Reference Number: EMA/779345/2011

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

Reference Number: EMA/822577/2011

Presentation - Update on the list of Union reference dates and frequency of periodic-safety-update-report submission

Presentation - Guidance on transitional measures for the pharmacovigilance legislation

Presentation - Public consultation on a concept paper on implementing measures for the performance of pharmacovigilance activities

Presentation - Commission call for expression of interest for the position of member of the Pharmacovigilance Risk Assessment Committee

Presentation - Pharmacovigilance system master file – an approach towards system simplification

Presentation - Feedback from the informal Heads of Medicines Agencies (HMA) meeting on 5th October 2011

Presentation - Good pharmacovigilance practices (GVP)

Presentation - Implementation of the EudraVigilance access policy

Presentation - Urgent union procedure

Multimedia