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.

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Session 2 of Highlighted Presentations Followed by Q&A

Speaker(s)

Vicki Edwards, RPH

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

Revision of ICH E2D – Scope and Status Update

Nick Halsey

Scientific Administrator, European Medicines Agency, Netherlands

The New Clinical Trial Legislation - Impact on EudraVigilance