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AI in pharmacovigilance – EMA update

Industry Stakeholder Platform Operation of EU Pharmacovigilance

20 October 2026

Luis Pinheiro (Data Analytics and Methods Task Force)
Julie Durand (Pharmacovigilance Office)

News & Trends

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Recentes

  • GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
  • New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
  • AI in pharmacovigilance – EMA update
  • Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”
  • New revision of the MDCG Position Paper on the management of SS(C)P in Eudamed after mandatory use
  • PIC/S RECOMMENDATION INTERPRETATION OF THE MOST IMPORTANT CHANGES IN THE ANNEX 1 ON THE MANUFACTURE OF STERILE PRODUCTS
  • EMA UPDATES :Notice to sponsors on validation and qualification of computerised systems used in clinical trials
  • ISO/TC 215 Task Force 5 WHITE PAPER: Healthcare-Specific Considerations for AI.

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