eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2023
EventHumanRegulatory and procedural guidance
Date
- Monday, 27 November 2023, 09:00 (CET) - 13:00 (CET)
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
The training focuses on:
- 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.