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

EventHumanPharmacovigilance

Date

, -

Location

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.

Documents

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

English (EN) (270.68 KB - PDF)

First published: Last updated:
View

Presentations

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

English (EN) (802.05 KB - PDF)

First published:
View

Presentation - ICH E2D and ICH E2B updates (A.Van Haren, MEB; G.Touraille, EMA; T.Paternoster-Howe, EMA)

English (EN) (4.77 MB - PDF)

First published:
View

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

English (EN) (463.59 KB - PDF)

First published:
View

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

English (EN) (854.41 KB - PDF)

First published:
View

Presentation - Best practice for signal assessment - NCA perspective (B.Mulder, MEB)

English (EN) (3.43 MB - PDF)

First published:
View

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

English (EN) (509.66 KB - PDF)

First published:
View

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

English (EN) (1.1 MB - PDF)

First published:
View

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

English (EN) (1.52 MB - PDF)

First published:
View

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

English (EN) (1.48 MB - PDF)

First published:
View

Presentation - AI in pharmacovigilane - Industry perspective

English (EN) (1.11 MB - PDF)

First published:
View

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

English (EN) (2.55 MB - PDF)

First published:
View

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

English (EN) (1.62 MB - PDF)

First published:
View

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

English (EN) (2.03 MB - PDF)

First published:
View

Share this page