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

• Date:
  сряда, 17 November 2021 , 09:00 - 13:15 Amsterdam time (CET)
• Местоположение:
  Online
  European 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

Documents

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

Reference Number: EMA/526063/2021

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

Reference Number: EMA/582239/2021 Corr.

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

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

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

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

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

Registration

• Registration by invitation only
• Registration closed