First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection

• Date:
  streda, 05 november 2025 , 09:00 - 17:00 Amsterdam time (CET)
• Miesto:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are hosting the first EMA/HMA multi-stakeholder forum on EudraVigilance and signal Detection.

The Forum’s main objectives are to inform stakeholders on ongoing and forthcoming developments in international guidance, adverse drug reaction case processing, signal management and data analysis in EudraVigilance, and to foster stakeholder engagement and collaboration to further strengthen these areas.

Video recording

Documents

Agenda - First EMA-HMA multi-stakeholder forum on EudraVigilance and signal detection

Summary report - First EMA-HMA multi-stakeholder forum on EudraVigilance and signal detection

Presentations

Session 1

Presentation - ADR Data Quality Framework - Development, summary and next steps (T.Paternoster-Howe, EMA)

Presentation - ICH E2D and ICH E2B updates (A.van Haren, Medicines Evaluation Board; G.Touraille, EMA; T.Paternoster-Howe, EMA)

Presentation - Impact of the EudraVigilance Signal Detection Pilot termination by MAHs: IR.(EU)2025/1466, amendment of IR (EU)520/2012 (E. Savvaidou, EMA)

Session 2

Presentation - Industry perspective on signal management (J.Zanetic, Teva; A.Kubavat, Sandoz; R. Van Eemeren, Amgen)

Presentation - Best practice for signal assessment - NCA perspective (B.Mulder, Medicines Evaluation Board)

Session 3

Presentation - Achievements and impact of the Medical Literature Monitoring (MLM) service - A retrospective review of the first 10 years (T.Paternoster-Howe, EMA)

Presentation - Automated compliance monitoring based on reporting timelines (R.Nic An Ri, EMA)

Presentation - The use of EV data and common inspection findings (Dr.Jahn, Paul-Ehrlich-Institut)

Session 4

Presentation - SMART Methods Working Group: Harnessing collective expertise to strengthen signal detection (C.Zaccaria, EMA)

Presentation - AI in pharmacovigilane - Industry perspective

Presentation - CIOMS Working Group XIV upcoming report on AI in pharmacovigilance (J.Durand, EMA)

Session 5

Presentation - Updates on EudraVigilance (J.Caetano, EMA)

Presentation - Medicinal product reporting - EU implementation of ISO IDMP: from XEVMPD to PMS (A.van Haren, Medicines Evaluation Board; A.Cochino, EMA)