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 Pharma eReport Blog

Date: 18th May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance

XEVMPD e-Learning Course now online

The eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-Learning Course from the EMA is now live online and available for streaming.  The videos will be available for download and as a podcast via iTunes or RSS from week beginning 21st May.

The course has been designed to facilitate the practical implementation of the electronic submission of information on medicines by Marketing Authorisation Holders in the European Union in the light of the new pharmacovigilance legislation.

The e-learning course provides self-paced learning activities focusing on the explanation of the business requirements, technical aspects and operational procedures for the electronic submission of information on medicines. It provides guidance on the mandatory data elements necessary for the generation of eXtended EudraVigilance Product Report Messages (XEVPRMs) and outlines the use of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) data entry tool also known as EVWEB.

After finishing this e-learning course, an XEVMPD knowledge evaluation can be performed. If this knowledge evaluation is perfomed successfully, the EMA will provide the user with a notification of successful completion of the XEVMPD knowledge evaluation.

The 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). A notification of successful completion of the XEVMPD knowledge evaluation will be required for one user before the electronic submission process can be initiated by an MAH.

 

 

 

 

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