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European Medicines Agency

21 nov 2023 9:30 a.m. - 21 nov 2023 5:30 p.m.

Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands

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.

Quality Aspects related to EudraVigilance - Part 1

Speaker(s)

Magnus  Ysander, MD

EU QPPV role in relation to EudraVigilance & Signal Management

Magnus Ysander, MD

AstraZeneca, Sweden

EU & UK QPPV & Head Pharmacovigilance Excellence

Katharina  Weber

Pharmacovigilance Inspections - key aspects and findings

Katharina Weber

AGES, Austria

PV Assessor

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