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)

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

Gilles Touraille, PharmD, PhD

European Medicines Agency, Netherlands

Scientific Administrator

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

Rodrigo Postigo

European Medicines Agency, Netherlands

Scientific Administrator

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

Florence van Hunsel, PharmD, PhD

Netherlands Pharmacovigilance Centre Lareb, Netherlands

Head Signal Detection

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EMA EudraVigilance & Signal Management Virtual Information Day

Session 3 of Highlighted Presentations Followed by Q&A

Speaker(s)

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

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

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

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