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

EventHumanPharmacovigilance

Italian is available via eTranslation, the European Commission's machine translation service.

Translate to Italian | Important information about machine translation

Data

, -

Posizione

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

English (EN) (270.68 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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

English (EN) (309.42 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

Presentations

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

English (EN) (802.05 KB - PDF)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (4.77 MB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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

English (EN) (463.63 KB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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

English (EN) (854.41 KB - PDF)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (3.43 MB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (1.1 MB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

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

English (EN) (1.52 MB - PDF)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (1.48 MB - PDF)

Pubblicato per la prima volta:
Visualizza

Presentation - AI in pharmacovigilane - Industry perspective

English (EN) (1.11 MB - PDF)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (2.55 MB - PDF)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (1.62 MB - PDF)

Pubblicato per la prima volta:
Visualizza

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

English (EN) (2.03 MB - PDF)

Pubblicato per la prima volta: Ultimo aggiornamento:
Visualizza

Share this page