For whom has the EudraVigilance Training Programme been designed for?

The EudraVigilance Training Programme has been designed for:

• SMEs that intend to use EVWEB to implement electronic transmission of safety data. SMEs will be required to follow a training course in order to ensure the correct use of the reporting tool. SMEs can apply for more than one person to be trained, or alternatively, send only one person who will subsequently train other users internally.

• Pharmaceutical companies that perform electronic transmission of ICSRs and wish to access the information related to their own ICSRs and medicinal products contained in the system. Using this locally established ICH compliant data processing network (Gateway) and management system, pharmaceutical companies may wish to attend this course to learn how to access and query the ICSRs that they have submitted to EudraVigilance.

• National Competent Authorities that wish to acquire knowledge in the functionalities of the tool, specifically in relation to data retrieval and evaluation, to facilitate the scientific use of the data contained in the database