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European Medicines Agency

2023 年 11 月 21 日 9:30 上午 - 2023 年 11 月 21 日 5:30 下午

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.

CONTACT US

Send Email +41.61.225.51.51

CONTACT US

Send Email +41.61.225.51.51

返回 Agenda

Quality Aspects related to EudraVigilance - Part 3

Speaker(s)

Michelle Grimes, MSc

Update on the revision of ICH E2D(R1) Guideline

Michelle Grimes, MSc

MSD, United Kingdom

Head, International Pharmacovigilance. GCS&PV

Tom Paternoster-Howe, MSc

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

Veronica Lipucci Di Paola

SPOR activities with focus on product and signal detection

Veronica Lipucci Di Paola

European Medicines Agency, Netherlands

Master Data Manager

Marcos Fernandez Gomes

Marcos Fernandez Gomes

European Medicines Agency, Netherlands