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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
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.
9:30 AM — 9:50 AM
9:50 AM — 10:00 AM
10:00 AM — 10:35 AM
Data Protection with regard to EudraVigilance10:35 AM — 11:15 AM
Quality Aspects related to EudraVigilance - Part 111:15 AM — 11:45 AM
11:45 AM — 12:40 PM
Quality Aspects related to EudraVigilance - Part 212:40 PM — 1:40 PM
1:40 PM — 3:20 PM
Quality Aspects related to EudraVigilance - Part 33:20 PM — 3:40 PM
3:40 PM — 5:00 PM
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