EMA's hands-on training course works through the mandatory ISO/ICH E2B(R3) format for individual case safety reports (ICSRs) using the EudraVigilance system, running – at the European Medicines Agency in Amsterdam — part of a recurring course series EMA runs several times a year for pharmacovigilance reporting staff.
Dates and format
- Dates: 7–11 December 2026
- Location: European Medicines Agency, Amsterdam (per EMA's own page) — a DIA-hosted mirror of the listing instead describes it as a virtual live course; this directory could not resolve the discrepancy from the sources available
- Organizer: European Medicines Agency
- Course focus: mandatory ISO/ICH E2B(R3) individual case safety reporting using the EudraVigilance system
What it covers
The ISO ICSR/ICH E2B(R3) format has been mandatory for EudraVigilance reporting since 30 June 2022, and this hands-on course works through the mechanics in detail: creating, sending and accessing ICSRs in the required format, using the EudraVigilance web application, and transmitting through the EudraVigilance Gateway. EMA's course series also covers the EudraVigilance business rules and access policy that govern who can submit and view reports.
Who should attend
Pharmacovigilance and drug-safety staff who submit or review ICSRs — Gateway and WebTrader users, sponsors' safety teams, and national competent authority staff analysing suspected adverse reactions. This is a recurring EMA course; organisations that missed an earlier 2026 session or need to onboard new reporting staff are the natural audience for the December run.
Working through a broader pharmacovigilance calendar? EMA's EudraVigilance Signal Detection Forum runs in early December too, and DIA's Pharmacovigilance Audits and Inspections course covers the compliance side; the full events directory lists everything we have verified.
Frequently asked questions
What does this EudraVigilance training course cover?
It is a hands-on course on the mandatory ISO/ICH E2B(R3) format for individual case safety reports (ICSRs): creating, sending and accessing ICSRs, using the EudraVigilance web application, Gateway transmission, and EudraVigilance's business rules and access policy.
Is the course in person or virtual?
Sources disagree. EMA's own event listing describes an in-person course at the European Medicines Agency in Amsterdam; a DIA-hosted mirror of the same listing calls it a virtual live course. Confirm the delivery mode on EMA's own registration page before making travel plans.
Who should attend?
Pharmacovigilance professionals responsible for ICSR submission to EudraVigilance, including Gateway and WebTrader users, sponsors' safety teams, and staff at national competent authorities who report or analyse suspected adverse reactions.
Sources & further reading
- EMA. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, 7-11 December 2026. ema.europa.eu
- DIA. EMA Course Listing — Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting, December 2026. diaglobal.org
Event details are published by the organizer and can change. Confirm dates, format (in-person vs. virtual is unresolved between sources), registration and fee with EMA before making plans. Verified through search corroboration only — direct fetch of ema.europa.eu was blocked this session; last checked 23 October 2026.
