20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Date:
  Giovedì, 13 Novembre 2025 , 13:30 - 17:40 Amsterdam time (CET)
• Sede:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The 20th meeting of the industry stakeholder platform on the operation of EU pharmacovigilance aims to inform, get feedback and foster dialogue between industry and the EU regulators.

Topics include:

• Real World Evidence update
• Guidance update
• EudraVigilance updates
• Update on AI initiatives in the field of PhV  
• Drug-device fixed combinations for reporting ADRs/incidents.

The highlights and presentations from the meeting are published after the event.

Documents

Highlights - 20th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation meeting

Reference Number: EMA/370879/2025

Agenda - 20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

Reference Number: EMA/147010/2025

Presentation - HMA-EMA catalogues of real-world data (RWD) sources and studies (K-C. Deli, EMA)

Presentation - Real world evidence update (A. Segec, EMA)

Presentation - Update on the EU-good pharmacovigilance practices (EU-GVP) (P. Bahri, EMA)

Presentation - Termination of the pilot of signal detection in EudraVigilance by marketing authorisation holders (MAHs) (S. Eleni, EMA)

Presentation - AI in pharmacovigilance – EMA update (L. Pinheiro, J. Durand, EMA)

Presentation - Compiance monitoring based on reporting timelines (T. Paternoster-Howe)