EMA launches XEVMPD e-learning course to support Article 57(2) compliance and further updates XEVMPD controlled vocabularies

The European Medicines Agency (EMA) has launched the long-awaited XEVMPD e-learning course to support compliance of Marketing Authorisation Holders (MAHs) with Art. 57 (2) of Regulation (EC) No. 726/2004.

The course is comprised of six modules which cover:

1. Introduction to the Eudravigilance system
2. Regulatory background
3. XEVMPD architecture
4. Submission of the XEVPRM with practical examples
5. XEVMPD data entry tool EVWEB
6. XEVPRM operation types

The XEVMPD e-Learning course is freely accessible via the following methods:

• Streaming (via YouTube)
• Downloading the videos (announced to be available during this week)
• Podcast via iTunes or RSS (announced to be available during this week)

An EVWEB user manual is also available for download.

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In addition, some controlled vocabularies of the XEVMPD have been updated by the Agency:

• Organisations (WC500123647), version 3.0
• Substances (WC500123652), version 4.0
• Reference Sources (WC500123649), version 2.0

All vocabularies are available as MS Excel spreadsheets from the Agency`s website.

[Source: EMA]

Related News:

 EMA releases further updated XEVMPD controlled vocabularies for Substances and Organisations - 29.05.2012 16:56

 EMA releases version 3 of the Controlled Vocabulary for XEVMPD Substances - 08.05.2012 10:30

 New XEVMPD controlled vocabularies published by EMA - 30.04.2012 10:56

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