16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance , Online, 09:00 - 13:15 Amsterdam time (CET), from 17/11/2021

E

EMA Events

Guest
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 aRMMs/follow-up questionnaires of the reference products (also from an industry perspective)
  • EMA medical literature monitoring service update

Sumber : https://www.ema.europa.eu
 
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