EudraVigilance and signal management information day

Event summary

This information day will cover:

how the mandatory use of ISO standard terminology for pharmaceutical form and route of administration for reporting individual cases of suspected side effects from 30 June 2022 will affect the use of European Directorate for the Quality of Medicines and HealthCare (EDQM) terms, including necessary technical adaptations;
the impact of the COVID-19 pandemic and the authorisation of COVID-19 vaccines on EudraVigilance in the context of signal detection and management;
a proposed update of the ICH E2D guideline on post-approval safety data management to clarify how to manage post-approvals safety information from new or increasingly used data sources;
the EudraVigilance Operational Plan - Milestones 2020 to 2022 and key milestones.

Agenda and registration form - European Medicines Agency EudraVigilance and signal management information day

English (EN) (190.49 KB - PDF)

First published: 13/10/2021

To register and for any questions, please visit the event page on DIA's website or use the registration form included above.
Places are limited.