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

Date: 17/11/2021
Location: Online, 09:00 - 13:15 Amsterdam time (CET)

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 by invitation only
  • Registration closed

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