18th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Data:
  Wednesday, 22 November 2023 , 13:00 - 16:30 Amsterdam time (CET)
• Post:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This virtual meeting aimed to inform, get feedback and foster dialogue between industry and the EU regulators.

Topics included:

• artificial intelligence in pharmacovigilance; 
• update on good pharmacovigilance practice; 
• risk management plans, including EMA transparency measures and guideline on specific adverse reaction follow-up questionnaires; 
• updates on PASS with the catalogues to replace the current ENCePP resources database, and the EU PAS register
• EudraVigilance update.

Documents

Agenda – 18th industry stakeholder platform – operation of EU pharmacovigilance

Adopted Reference Number: EMA/296352/2023

Presentation - Update on AI in pharmacovigilance at EMA (J. Durand, EMA)

Presentation - Update on Good Pharmacovigilance Practices (EU-GVP) (P. Bahri, EMA)

Presentation - RMP publication and Specific adverse reaction Follow-up questionnaires guideline (E. Cochino, EMA)

Presentation - EMA/HMA catalogue of non-interventional studies (EU PAS Register) - new functionality (A. Cochino, EMA)

Presentation - GVP Module VIII - Post-authorisation safety studies (C. Jonker, EMA)

Highlights from the 18th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 22 November 2023

Reference Number: EMA/532475/2023