Sponsors of clinical trials are responsible for providing information on Investigational Medicinal Products (IMPs) in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) in accordance with Article 81(3) of CT Regulation (EU) No 536/2014.

The EMA has prepared this live virtual training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on un-authorised referred to in the XEVMPD as development medicinal products (DMPs) by commercial and non-commercial sponsors of clinical trials in the European Economic Area (EEA).

The training focuses on explaining the guidance and mandatory data elements necessary for the electronic submission of information on development medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes practical exercises in EVWEB for the electronic submission and maintenance of development medicinal product information.

Participants, who successfully pass the knowledge evaluation following the training course, will receive a notification of successful completion of this training course from the European Medicines Agency. This notification is requested from at least one user from the sponsor organisation during the organisation’s registration with EudraVigilance for the electronic submission of information on DMPs. The aim is to ensure the quality of data submitted to the XEVMPD.

Mandatory pre-course installations are required for this training course. Refer to the technical requirements tab for more information.