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:
Training
EMA organises training courses 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) training course
| Target audience |
|
| Duration | 1.5 days |
| Topics covered |
|
| Available training dates |
Short training for clinical trial sponsors
EMA organises shorter training courses specifically for clinical trial sponsors. These focus on how to add investigational medicinal product information to the XEVMPD.
EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors
| Target audience |
|
| Duration | 1 day (two half days) |
| Topics covered |
|
| Available training dates |
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 unauthorised medicinal products (referred to in the XEVMPD as 'development medicinal products').
The course is available as a series of presentations, videos and step-by-step guides available on this web page. Users must also review the guidance document(s) related to the submission of authorised or development medicinal product data. Access is free of charge.
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:
- 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 of e-learning course
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.
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 registerfor the knowledge evaluation, submit a request to EMA Service Desk. Please specify if your request concerns knowledge evaluation for authorised medicinal product data or development medicinal product data or both.
Users who have received notification of successful completion can train other users within their organisation.
Following their registration, participants will receive instructions on how to obtain access to the XEVMPD test environment (XCOMP). Access is limited to eight 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(s): 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.