16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

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

Agenda - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

Reference Number: EMA/526063/2021

English (EN) (476.24 KB - PDF)

First published: 02/12/2021

Highlights - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

Reference Number: EMA/582239/2021 Corr.

English (EN) (171.62 KB - PDF)

First published: 06/12/2021 Last updated: 10/12/2021

Presentation - Monitoring of COVID-19 products: toolkit (Agnieszka Szmigiel, Emil Cochino)

English (EN) (1.85 MB - PDF)

First published: 02/12/2021

Presentation - Good Pharmacovigilance Practices (EU-GVP) (Priya Bahri)

English (EN) (353.05 KB - PDF)

First published: 02/12/2021

Presentation - Guideline on registry-based studies (Kelly Plüschke)

English (EN) (541.29 KB - PDF)

First published: 02/12/2021

Presentation - EMA medical literature monitoring service update (Tom Paternoster-Howe)

English (EN) (210.42 KB - PDF)

First published: 02/12/2021

Presentation - Periodic safety update report (PSUR): Adherence to PRAC recommendations for national authorized products (NAPs) (Viola Sarinic)

English (EN) (769.6 KB - PDF)

First published: 03/12/2021