EudraVigilance Workshop – Electronic reporting of Individual Case Safety Reports (ICSRs) in the European Economic Area (EEA)
An Eudravigilance workshop on the electronic reporting of Individual Case Safety Reports (ICSRs) in the European Economic Area (EEA), organised by Drug Information Association (DIA) and the European Medicines Agency (EMA) will be organised from 14-19 September 2014 in Zagreb. The workshop will be held at HALMED’s premises in the Robert Frangeš Mihanović Street 9 (Sky Office Business Building).
The workshop is intended for EudraVigilance system users and all those others who are interested to use it. One or more representatives from the same company may register for the workshop. Upon completion of the workshop, they will be qualified for providing in-house staff education within the company. The workshop will end with a test. Successful candidates will be delivered certificates on the completed course and will be entitled to report ICSRs to the EMA and/or national competent authorities by using the EudraVigilance System.
This workshop is the only training program recognised by the European Medicines Agency. HALMED implemented the EudraVigilance System in March 2010.
Detailed information, program and registration form are accessible here.