European Medicines Agency - Implementation of new Pharmacovigilance Legislation
European Medicines Agency has published audio and video content related "Implementation of new Pharmacovigilance Legislation
It includes information on following topics:
- Update from EMA on planning and prioritization.
- Feedback on the implementing measures for the performance of Pharmacovigilance activites
- Planning for guidance on transitional measures
- Pharmacovigilance system master file: An approach towards system simplification
- Good vigilance practice - structure, scope and planning
- Commission appointments to the Pharmacovigilance Risk Assessment Committee (PRAC)
- Periodic safety update reports: Update on union reference dates list
- Access to EudraVigilance data - demonstration
- Urgent union procedure, including the concept of public hearings
- Conclusions
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