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 1

Speaker(s)

EU QPPV role in relation to EudraVigilance & Signal Management

Magnus Ysander, MD

AstraZeneca, Sweden

EU & UK QPPV & Head Pharmacovigilance Excellence

Pharmacovigilance Inspections - key aspects and findings

Katharina Weber

AGES, Austria

PV Assessor