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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Quality Aspects related to EudraVigilance - Part 3

Speaker(s)

Update on the revision of ICH E2D(R1) Guideline

Michelle Grimes, MSc

MSD, United Kingdom

Head, International Pharmacovigilance. GCS&PV

Medical Literature Monitoring Service - Significant updates for MAHs

Tom Paternoster-Howe, MSc

European Medicines Agency, Netherlands

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

SPOR activities with focus on product and signal detection

Veronica Lipucci Di Paola

European Medicines Agency, Netherlands

Master Data Manager

Marcos Fernandez Gomes

European Medicines Agency, Netherlands

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EMA EudraVigilance and Signal Management Information Day

Quality Aspects related to EudraVigilance - Part 3

Speaker(s)

Update on the revision of ICH E2D(R1) Guideline

Medical Literature Monitoring Service - Significant updates for MAHs

SPOR activities with focus on product and signal detection

Marcos Fernandez Gomes

Be informed and stay engaged.