European Medicines Agency launches new e-learning course for Article 57(2) requirements on submission of information on medicines

16 May 2012

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 XEVPRM with practical examples;
• the XEVMPD data entry tool also known as EVWEB.

The modules are cost-free to access and can be streamed live from today or can be downloaded from early next week. On completion of the e-learning course, participants are able to take a knowledge evaluation test.

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 XEVMPD. A notification of successful completion of the XEVMPD knowledge evaluation provided by the Agency will be required for one user before the electronic submission process can be initiated by a marketing-authorisation holder as per Article 57(2) of Regulation (EU) No 1235/2010.

The e-learning course complements existing training initiatives including classroom training and guidance material available on the Agency's website.