General

EudraVigilance (EV)

Pharmacovigilance

MedDRA

EudraVigilance Training Programme

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-Learning Course

Electronic submission of information on medicines - New pharmacovigilance legislation (Art. 57, paragraph 2, Regulation (EC) No. 726/2004).

Overview of the e-learning course

The European Medicines Agency (EMA) has prepared the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning course to facilitate the practical implementation of the electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) in the context of the new pharmacovigilance legislation. This XEVMPD e-Learning course is accessible for free.

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.
This e-learning course does not cover:

  • Training in developing and validating information or communication technology tools to produce messages compliant with the published XEVPRM and SSI XSD schemas
  • Training on all five ISO Identification of Medicinal Products (IDMP) standards and the Individual Case Safety Report (ICSR) standard as well as related ICH Implementation Guides
  • Training on IDMP, ICSR and Common Product Model (CPM) HL7 messages

How to participate

To participate in the XEVMPD e-learning training course, the following materials should be reviewed:

Session 4.1

Live Demonstration - How to Insert a Marketing Authorisation Holder and Sponsor Organisation

Session 4.3

Live Demonstration - How to Insert a Development Medicinal Product

Session 4.4

Live Demonstration - How to Insert an Authorised Medicinal Product (Mutual Recognition Procedure Product)

Session 4.5

Live Demonstration - How to insert an Authorised Medicinal Product (Centrally Authorised Product, vaccine)

Session 4.6

Live Demonstration - How to insert an Authorised Medicinal Product (Nationally Authorised Product)

Session 5.1

Live Demonstration - How to Perform Simple and Advanced Queries in the XEVMPD

Session 6.3

Live Demonstration - How to Perform an Update Type Operation on Marketing Authorisation Holder Organisation

The above training videos are currently being updated to reflect changes to the Article 57 format and XSD schema applicable as of 16 June 2014. The following Step-by-Step guides have been created to provide you with the most up-to-date information during this period:

Notification of successful completion of the XEVMPD knowledge evaluation

After finishing this e-learning course, an XEVMPD knowledge evaluation can be performed. If this knowledge evaluation is performed successfully, the EMA will provide the user with an e-mail notification of successful completion of the XEVMPD knowledge evaluation.
At least one user from an MAH/sponsor organisation 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).

Notification of successful completion of the XEVMPD knowledge evaluation is requested for one user during the EudraVigilance registration process before the electronic submission process can be initiated. Full details of the registration process are available Registration for EudraVigilance.

To register for the XEVMPD knowledge evaluation please contact evtraining@ema.europa.eu. Please note that a maximum of five users from the same organisation can be registered for the XEVMPD knowledge evaluation. Participants will receive a password and user name to allow them access to the EVWEB training environment. This access is limited to 4 weeks. It is recommended that participants register for the XEVMPD knowledge evaluation once they reviewed the training videos and training material in order to perform the XEVMPD knowledge evaluation, taking into account any possible subsequent attempts.
The XEVMPD knowledge evaluation consists of two parts:

  • Part I: Multiple Choice Questionnaire
    Participants will be asked to answer 20 questions. There is one correct answer for each question. At least 16 questions (=80%) have to be answered correctly to receive a passing score.
  • Part II: Product Report Exam Case
    In this part of the knowledge evaluation, participants will be requested to enter a fictitious Product Report Message to the XEVMPD training environment on the basis of the supporting documents received together with the login details.

Participants have three attempts to pass each section of the knowledge evaluation. Please see the Training FAQs section for additional information on the XEVMPD knowledge evaluation and e-learning.

 

 

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Last update: Wednesday, 30 September 2015.

 

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