It is common knowledge that pharmaceutical companies who are applying for or already have a Marketing Authorisation (MA) in the EEA need to be registered with EudraVigilance to be able to carry out vital pharmacovigilance activities.
The EMA is soon opening up its virtual doors to the EudraVigilance Data Analysis System (EVDAS). They recently published a step-by-step guide explaining the process of requesting access for both National Competent Authorities (NCA) and MA holders. The EMA have also provided assigned time slots during which specific MA holders should register for EVDAS access (NCA don’t have a schedule to follow).
Up to 5 EVDAS users can be selected at company headquarter level. These users will be able to access and make electronic reaction monitoring reports and line listings, as well as access active substance groupings and individual case safety report forms.
For more information on EVDAS and the registration process please click here.