概览
EudraVigilance (EV) is the EU’s system for managing and analysing
information on adverse reactions to medicines which have been
authorised or are being studied in clinical trials in the European Economic
Area (EEA). The use of the ISO Individual Case Safety Report (ICSR)
standard based on the ICH E2B (R3) modalities became mandatory on 30
June 2022.
Following the completion of this course, participants who pass the
knowledge evaluation will receive a notification from the EMA.
Organisations which aim to register first user RP or to use EudraVigilance
web application (EVWEB) to start the electronic reporting of ICSRs to
EudraVigilance for the first time, need to provide such notification for at
least one user to the EMA to be able to successfully register with the EV
production environment. For more information on the registration process,
please consult the EMA website.