eXtended EudraVigilance medicinal product dictionary face-to-face training course

• Date:
  Thursday, 21 June 2018
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on 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 exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.