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Virtual

Nov 24, 2021 7:30 PM - Nov 24, 2021 11:30 PM

(Central Europe Standard Time)

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 3 of Highlighted Presentations Followed by Q&A

Speaker(s)

Gilles Touraille, PHARMD, PHD

Gilles Touraille, PHARMD, PHD

Scientific Administrator, European Medicines Agency, Netherlands

COVID-19 Vaccines – Impact on Eudravigilance, Coding Guidelines and Transparency Aspects

Rodrigo Postigo

Rodrigo Postigo

Signal Management Lead, Pharmacovigilance Office, European Medicines Agency, Netherlands

COVID-19 Vaccines – Impact on Eudravigilance, Coding Guidelines and Transparency Aspects

Florence van Hunsel, PHARMD, PHD

Florence van Hunsel, PHARMD, PHD

Head Signal Detection, Netherlands Pharmacovigilance Centre Lareb, Netherlands

COVID-19 Vaccines ICRSRS – A National Competent Authority (NCA) Perspective

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