Date
- Wednesday, 17 November 2021, 09:00 (CET) - 13:15 (CET)
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
This meeting aims to foster dialogue between industry and EU regulators.
Topics include the following:
- Monitoring of COVID-19 products
- PSURs: adherence to PRAC recommendations for nationally authorised products (NAPs)
- Good pharmacovigilance practice (GVP) update
- Update on the guideline on registry-based studies
- Industry perspective on post authorisation safety studies (PASS) impact and pharmacovigilance obligations
- Access of the off-patent sector to additional risk minimisation measures (aRMMs) and follow-up questionnaires of the reference products (also from an industry perspective)
- EMA medical literature monitoring service update
Registration
- Registration by invitation only
- Registration closed