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)

ICSRs data quality findings - dos and don'ts

Tom Paternoster-Howe, MSc

European Medicines Agency, Netherlands

Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data

Go-live of new EudraVigilance reporting compliance reports

Gilles Touraille, PharmD, PhD