Explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on authorised and unauthorised (referred to in the XEVMPD as 'development') medicinal products;
Applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM);
The use of the XEVMPD data entry tool (EVWEB).
It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of development medicinal products.