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 3

Speaker(s)

Michelle Grimes, MSc

Head, International Pharmacovigilance. GCS&PV, MSD, United Kingdom

Update on the revision of ICH E2D(R1) Guideline

Tom Paternoster-Howe, MSc

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

Medical Literature Monitoring Service - Significant updates for MAHs

Veronica Lipucci Di Paola

Master Data Manager , European Medicines Agency, Netherlands

SPOR activities with focus on product and signal detection

Marcos Fernandez Gomes

, European Medicines Agency, Netherlands