EMA EudraVigilance and Signal Management Information Day

The first onsite EudraVigilance and Signal Management information day since 2018 is dedicated to update on EudraVigilance data protection activities, SPOR data activities, the revision of ICH-E2D, ICSRs quality control, key aspects and findings in PV Inspections related to EudraVigilance as well as EudraVigilance Operational activities.

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返回 Agenda

Quality Aspects related to EudraVigilance - Part 2

Speaker(s)

Tom Paternoster-Howe, MSc

Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data, European Medicines Agency, Netherlands

ICSRs data quality findings - dos and don'ts

Gilles Touraille, PharmD, PhD

Scientific Administrator, European Medicines Agency, Netherlands

Go-live of new EudraVigilance reporting compliance reports