The European Medicines Agency has launched an e-learning course for marketing authorisation holders to support compliance with Article 57(2) on the submission of information on medicines, one of the key measures of the new pharmacovigilance legislation.
The course is comprised of six modules which cover:
- an introduction to the Eudravigilance system;
- the regulatory background;
- the architecture of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD);
- submission of the eXtended EudraVigilance Product Report Message (XEVPRM) with practical examples, and;
- the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) data entry tool also known as EVWEB.
The modules are free to access and can be streamed live now or will be available for downloading (download will be available early next week). Part of the course is a knowledge evaluation test. A notification of successful completion of this test will be required for one user before the electronic submission process can be initiated by a MAH as per Article 57(2) of Regulation (EU) No 1235/2010.
EMA recommends that at least one user from each marketing authorisation holder should be trained to understand how to submit medicinal product data to the Agency and to ensure quality of medicinal product data submitted to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
To see the training programme: http://eudravigilance.ema.europa.eu/human/training7.asp
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