Extended EudraVigilance medicinal product dictionary (XEVMPD) training

  • Email
  • Help

The European Medicines Agency (EMA) offers training on how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 database. This is aimed at ensuring the quality of data in the XEVMPD on authorised or investigational medicinal products. At least one user from each marketing authorisation holder or sponsor of clinical trials should receive training. 

Users who have successfully completed the training offered by the Agency and the EudraVigilance registration process can start to submit data to the Agency.

If a company has made arrangements with a third-party service provider to submit data on medicines on their behalf, it is sufficient that a staff member of the third-party service provider has successfully completed the training.

XEVMPD training is also available to users from national competent authorities.

The syllabus focuses on product data submission and the use of the data entry tool, EVWEB:

E-learning

The e-learning course enables self-paced learning focusing on explaining the business requirements, technical aspects and operational procedures for data submission of authorised and investigational medicinal products.

The course is available as a series of presentations, videos and step-by-step guides. Access is free of charge. 

XEVMPD e-learning presentations

Step-by-step guides

As the training videos do not reflect changes to the Article 57 format and XSD (extensible markup language schema definition) schema applicable as of 16 June 2014, step-by-step guides were created to provide up-to-date information:

This course does not cover:

Notification of successful completion

After finishing the e-learning course, users can perform an XEVMPD knowledge evaluation. If users perform this knowledge evaluation successfully, the Agency will provide them with a notification of successful completion. At least one user from a company must obtain this during the EudraVigilance registration process before data submission can begin.

Update: Companies can register a maximum of five users for the knowledge evaluation. They will not be able to register additional users if the registered users leave the company.

The aim of this service is to support companies in developing their in-house expertise and training courses for new staff and not to train users on an individual basis. EMA advises that companies plan accordingly and ensure internal knowledge transfer.

To register for the knowledge evaluation, contact evtraining@ema.europa.eu.

Users who have received notification of successful completion can train other users within their organisation.

Following their registration, participants will receive a username and password to grant access to the XEVMPD training environment. Access is limited to four weeks. The Agency recommends that participants register for the XEVMPD knowledge evaluation after they have reviewed the training material.

The XEVMPD knowledge evaluation consists of two parts:

  • Multiple choice questionnaire: participants have to answer at least 16 out of 20 questions correctly to pass;
  • Product report exam case: participants have to enter a mock product report message into the XEVMPD training environment based on supporting documents and login details.

Participants have three attempts to pass each section of the knowledge evaluation.

Face-to-face training

The Agency also arranges a face-to-face training course which includes theory and hands-on examples using the XEVMPD training environment.

During the training, participants will be able to discuss real-life scenarios with trainers and other participants and seek advice.

Extended EudraVigilance medicinal product dictionary (XEVMPD) face-to-face training course
Target audience
  • Marketing authorisation holders and sponsors of clinical trials
  • All prospective users of the XEVMPD who pass the knowledge evaluation will be able to register with EudraVigilance and submit medicinal product data to EMA
Duration1.5 days
Learning outcomes

After successfully completing the course, participants will be able to:

  • understand the legal requirements for marketing authorisation holders to comply with the provisions set out in Article 57(2) of Regulation (EC) 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012;
  • understand the requirements for sponsors of clinical trials as outlined in the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use’ (‘CT-3’) (OJ 2011/C 172/01);
  • be familiar with the extended EudraVigilance product report message (XEVPRM) format used for the electronic submission of information on authorised medicinal products as well as investigational medicinal products;
  • understand the controlled vocabularies and terminologies to be used during the submission process;
  • use the XEVPMD data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products;
  • explain the data structure of the extended EudraVigilance medicinal product dictionary (XEVMPD) for data entry and data retrieval;
  • understand the importance of the XEVMPD to support the pharmacovigilance activities in the EU.

 

How helpful is this page?

Average rating:

 Based on 27 ratings

Add your rating:

See all ratings
3 ratings
0 ratings
2 ratings
2 ratings
20 ratings
    

Tell us more

Related content

Related EU legislation

Related documents

Contact point:

For support with EMA information technology (IT) systems:
EMA Service Desk

For urgent technical matters:
Tel. +44 (0)20 3660 7523