EMA EudraVigilance & Signal Management Virtual Information Day

This virtual live Information Day will focus on the ISO 27953-2:2011 as well as ISO 11239:2012 standards which will become applicable as of 30 June 2022 for all reporting to EudraVigilance. It will also highlight the impact on EV and Signal Management with regard to COVID-19 and provides an update on the revision of the existing ICH-E2D.

返回 Agenda

Session 1 of Highlighted Presentations Followed by Q&A

Speaker(s)

EudraVigilance Operational Plan – Milestones 2020-2022

Anja Van Haren, MSC

Medicines Evaluation Board (MEB), Netherlands

Eudravigilance coordinator

Mandatory Use of the ISO Individual Case Safety Report (ICSR) Standard and The ISO Terminology on Pharmaceutical Dose Forms and Routes of Administration – Stakeholders Change Management

Nick Halsey

European Medicines Agency, Netherlands