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:
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
- Session 1.0: Introduction
- Session 1.2: Registration with EudraVigilance
- Session 2.4: Operation types, data quality and data ownership
- Session 3: Database architecture
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:
- Insert of an authorised medicinal product
- Insert of a development medicinal product
- Insert of organisation (marketing authorisation holder and sponsor)
- Insert of a master file location
- Update of an authorised medicinal product
This course does not cover:
- developing and validating information or communication technology tools to produce messages compliant with the published XEVPRM and structured substance information (SSI) XSD schemas;
- the five International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards, the individual case safety report (ICSR) standard or related International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) implementation guides;
- IDMP, ICSR and common product model (CPM) Health Level 7 (HL7) messages.
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.
To register for the knowledge evaluation, contact email@example.com.
A maximum of five users from the same organisation can be registered for the XEVMPD knowledge evaluation.
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.
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|
After successfully completing the course, participants will be able to:
|Available training dates|
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Related EU legislation
- eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training: frequently asked questions (2016-06-17)
- Article 57 QuickCard - Use of data elements in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) (2015-06-22)
- Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (2016) (2016-03-11)
For support with EMA information technology (IT) systems:
EMA Service Desk