2017 Pharmacovigilance Inspectors Working Group training course
Event
Corporate
Pharmacovigilance
Date
- Monday, 16 October 2017, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
The three-day pharmacovigilance inspectors training course is for inspectors and assessors of both, veterinary and human units of EU/EEA Member States, and delegates from non-EU countries. The training will consist of presentations as well as breakout sessions during which participants will be given case studies and examples to discuss and analyse within their group. The topics to be covered this year include: PhV inspection of third parties/contractors and contracts, signal management, harmonisation in grading of findings, the electronic submission of data on medicines to the EudraVigilance medicinal product dictionary (XEVMPD), harmonisation of detailed description of pharmacovigilance system (DDPS) of veterinary MAHs / management of corrective and preventive actions, reporting to EudraVigilance, use of EudraVigilance data analysis system and the use of medical dictionary for regulatory activities for human medicines (MedDRA) and veterinary medicines (VedDRA).