21st industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Dată:
  Marți, 20 octombrie 2026 , 13:00 - 17:30 Amsterdam time (CEST)
• Locația:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This 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:

• EudraVigilance updates 
• CMDh Work Plan 2026-2028
• AI initiatives in the field of PhV 
• Real World Evidence update 
• PSUR updates
• guidance update

Highlights and presentations from the meeting are published after the meeting.

Documents

Agenda - 21st industry stakeholder platform - operation of EU pharmacovigilance

Highlights - 21st industry stakeholder platform - operation of European Union (EU) pharmacovigilance

Reference Number: EMA/236746/2026

Presentation - 25 years of advancing patient safety together

Presentation - Automated compliance monitoring based on reporting timelines

Presentation - CMDh work plan 2026–2028

Presentation - AI in pharmacovigilance

Presentation - Real world evidence update

Presentation - PSUR assessment updates

Presentation - Update on the EU-good pharmacovigilance practices (EU-GVP)

Presentation - Draft GVP V and RMP template rev 3.0

Presentation - GVP Module IX, Rev.2 Signal management

Presentation - Revision of “Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling”