概览
This virtual live training course will teach concepts, access policy, and use of the EudraVigilance Data Analysis System (EVDAS) for signal detection. Experienced trainers using EVDAS on a regular basis will share practical advice on how to download and interpret the data and use it for signal detection.
The EudraVigilance data analysis system (EVDAS) supports EU pharmacovigilance safety monitoring activities with the focus on signal detection and evaluation of ICSRs. Marketing authorisation holders with active substances included in the list published by the European Medicines Agency have to monitor and inform authorities of validated signals with their medicines. GVP Module VII "Periodic Safety Update Reports" states that also for other active substances, MAHs are expected to include data from EudraVigilance whenever there are signal evaluations in the PSUR triggered by other sources of information.
The course is based on the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management, Commission Implementing Regulation (EU) No. 520/2012. Time has been set aside for practical exercises, questions, and discussions.
Participant Testimonials
The training was very efficient. I gained vast amount of information regarding access policy and valuable practical insight into the EVDAS. I would definitely recommend it to anyone who would like to refresh their knowledge regarding EVDAS or as a source of inspiration to improve their process. – Dr. Barbora Bujdosova – Drug Safety Manager, PRO.MED.CS, Czech Republic
