16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
Table of contents
Date:
17/11/2021
Location:
Online, 09:00 - 13:15 Amsterdam time (CET)
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
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Agenda - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance (PDF/476.24 KB)
First published: 02/12/2021
EMA/526063/2021 -
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Highlights - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance (PDF/171.62 KB)
First published: 06/12/2021
Last updated: 10/12/2021
EMA/582239/2021 Corr. -
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Presentation - Monitoring of COVID-19 products: toolkit (Agnieszka Szmigiel, Emil Cochino) (PDF/1.85 MB)
First published: 02/12/2021 -
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Presentation - Good Pharmacovigilance Practices (EU-GVP) (Priya Bahri) (PDF/353.05 KB)
First published: 02/12/2021 -
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Presentation - Guideline on registry-based studies (Kelly Plüschke) (PDF/541.29 KB)
First published: 02/12/2021 -
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Presentation - EMA medical literature monitoring service update (Tom Paternoster-Howe) (PDF/210.42 KB)
First published: 02/12/2021 -
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Presentation - Periodic safety update report (PSUR): Adherence to PRAC recommendations for national authorized products (NAPs) (Viola Sarinic) (PDF/769.6 KB)
First published: 03/12/2021