2015 Pharmacovigilance Inspectors Working Group training course
EventPharmacovigilance
Date
- Monday, 9 November 2015, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
The training is organised for human and veterinary inspectors and assessors from the European Union (EU) and the European Economic Area, as well as delegates from non-EU countries. It will consist of presentations and interactive breakout sessions. During the breakout sessions, participants will be given case studies and examples of inspection findings to discuss and analyse within their group.The topics to be covered this year include inspection planning and preparation, pharmacovigilance system master files and third parties, inspection of risk management plans, periodic safety update reports and interactions with Pharmacovigilance Risk Assessment Committee assessors, inspection grading and findings, databases, international collaboration and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation activities. Please see the programme for further details.