Back to Agenda
Session 1: Adverse Reaction Reporting and Analysis, EudraVigilance System Changes to Come
Session Chair(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
Anja Van Haren, MSc
Eudravigilance coordinator
Medicines Evaluation Board (MEB), Netherlands
Taking into account the requirements set out in pharmacovigilance legislation, this session will focus on the preparation for the use of the new data formatISO/ICH ICSR E2B(R3), for the simplified reporting to EudraVigilance, and for the implementation of the revised EudraVigilance Access Policy, which will lead to increased access to adverse reactions reports and industry responsibilities for signal detection.
Speaker(s)
Presentation and Discussion of the EudraVigilance Change Management Plan
Francois Domergue
European Medicines Agency, Netherlands
EV Auditable Requirement Project Manager, Business Data and Analytics Department
Revision of the EudraVigilance Access Policy on Suspected Adverse Reactions – Direction of Travel
Sabine Brosch, PharmD, PhD, MPharm
European Medicines Agency, Netherlands
Data Protection Officer
Have an account?