返回 Agenda
THE NEW EUDRAVIGILANCE SYSTEM - ONE YEAR ANNIVERSARY (PART II)
Session Chair(s)
Sabine Brosch, PHARMD, PHD, MPHARM
Data Protection Officer
European Medicines Agency, Netherlands
Anja Van Haren, MSC
Eudravigilance coordinator
Medicines Evaluation Board (MEB), Netherlands
This session will start with observations from a pharmacovigilance inspections perspective based on the application of the simplified reporting rules by MAHs in the EU. Taking into account the importance of high quality of data in EudraVigilance, initiatives to strengthen and improve the quality of ICSRs will be summarised. Frequently asked questions will be addressed based on a new set of do’s and don't’s for EudraVigilance. The expert panel will address further questions from the audience on the topics presented.
Speaker(s)
Elsa Ferrao
INFARMED, Portugal
Pharmacist
Simplified reporting rules and interaction with EudraVigilance Pharmacovigilance inspector’s perspective
Kiernan Trevett, MSC
Genentech, A Member of the Roche Group, United States
Quality Policy Lead
Initiatives to strengthen the quality of ICSR data
Sabine Brosch, PHARMD, PHD, MPHARM
European Medicines Agency, Netherlands
Data Protection Officer
EudraVigilance Dos’ and Dont’s – new aspects to be aware of
Anja Van Haren, MSC
Medicines Evaluation Board (MEB), Netherlands
Eudravigilance coordinator