Posted 16 May 2012
By Alexander Gaffney
A new course launched by the European Medicines Agency (EMA) aims to assist Marketing Authorization Holders (MAHs) comply with new Article 57(2) EudraVigilance regulations on the submission of information on medicines.
The six-part course covers the basics of the EudraVigilance system, the regulatory underpinnings of the system, which definitions are used in the system, the submission of EudraVigilance Product Report Messages and how to enter data.
Successful completion of the course is mandatory for at least one user of each MAH, as per Article 57(2) of EU Regulation 1235/2010. EMA notes this is to "ensure the quality of medicinal product data submitted to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
The training is provided by EMA at no cost, and may be found on EMA's website as both a streaming presentation and, starting next week, a downloadable presentation.
EMA - European Medicines Agency launches new e-learning course for Article 57 (2) requirements on submission of information on medicines