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

EventHumanPharmacovigilance

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

Translate to Romanian | Important information about machine translation

Date

, -

Locație

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)

Prima publicare: Cea mai recent:
Vizualizare

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

English (EN) (309.42 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

Presentations

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

English (EN) (802.05 KB - PDF)

Prima publicare:
Vizualizare

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)

Prima publicare: Cea mai recent:
Vizualizare

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)

Prima publicare: Cea mai recent:
Vizualizare

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

English (EN) (854.41 KB - PDF)

Prima publicare:
Vizualizare

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

English (EN) (3.43 MB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

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)

Prima publicare:
Vizualizare

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

English (EN) (1.1 MB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

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

English (EN) (1.52 MB - PDF)

Prima publicare:
Vizualizare

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

English (EN) (1.48 MB - PDF)

Prima publicare:
Vizualizare

Presentation - AI in pharmacovigilane - Industry perspective

English (EN) (1.11 MB - PDF)

Prima publicare:
Vizualizare

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

English (EN) (2.55 MB - PDF)

Prima publicare:
Vizualizare

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

English (EN) (1.62 MB - PDF)

Prima publicare:
Vizualizare

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)

Prima publicare: Cea mai recent:
Vizualizare

Share this page