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

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. 

To find more information please use the below mentioned weblinks

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/04/news_detail_001489.jsp&mid=WC0b01ac058004d5c1

http://eudravigilance.ema.europa.eu/human/training7.asp