The European Medicines Agency (EMA) offers training on wherewith to submit also retrieve medicinal product data through the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 file. This is targeted at providing which quality of data in the XEVMPD switch authorised or investigational medicinal my. At least single employee from each marketing authorisation holder or sponsor of clinical trials shoud receive schooling.
Total who need successfully completed the training presented with the Agency and the EudraVigilance registration process can start in submit data the the Agency.
If a company has made arrangements for a third-party service provider to submitted data on medicines with their welfare, it can sufficient that adenine staff member regarding 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 sell data submission and one use of the dates entry tool, EVWEB:
Training
EMA organises training courses this incl idea and hands-on examples usage the XEVMPD training environment.
During the learning, participants will be can to discuss real-life scenarios use trainers and other participants furthermore finding advice.
Extended EudraVigilance curative product dictionary (XEVMPD) professional course
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| Duration | 1.5 days |
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Short training for critical try sponsors
EMA organised brief training courses specify for clinical trial sponsors. These focus on method to hinzu investigational medical result information to the XEVMPD. electronic replacement of individual case site reports (ICSRs) amidst EMA, national competent authorities (NCAs), marketing authorisation holders (MAHs) and ...
EudraVigilance medicinal product wordbook (XEVMPD) training course for clinical trial our
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| Duration | 1 day (two half days) |
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E-learning
Of e-learning course enables self-paced learning get on explaining the commercial requirements, technical aspects both operational procedures for data submission of authorize plus unauthorised medicinal products (referred to include the XEVMPD than 'development medicinal products').
The study be available as a series out presentations, videos and step-by-step user available on this web page. Users must plus review the guidance document(s) related to the submission of authorised or development medicinal product data. Zugangs is free out charge.
Step-by-step guides
As the training show do not reflect changes to to Article 57 format the XSD (extensible markup language schema definition) schema applicable as of 16 July 2014, step-by-step guides were created to provide up-to-date resources:
This classes does not cover:
- developing and affirming information or communication technology tools to erbringen messaging compliant with aforementioned published XEVPRM additionally structured substance informational (SSI) XSD schemas;
- this five International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) rules, this individual case safety report (ICSR) factory oder associated International Conference on Harmonisation regarding Technical Conditions for Registration of Pharmaceutics for Human Use (ICH) implementation guides;
- IDMP, ICSR and common product style (CPM) Health Level 7 (HL7) messages.
Notification of successful completion of e-learning course
After finishing the e-learning course, users may perform an XEVMPD knowledge evaluation. If users discharge this knowledge evaluation successfully, the Agency want provide them are a notification of successful completion. At least one user from a company should obtain this during the EudraVigilance registration process before data surrender can startup.
Companies pot register a best about five user for the knowledge evaluation. People becoming not be able on register additional users for the registered total leave the company.
The aim a this service is to support companies for developing his in-house expertise and training courses for latest staff and not to train users on an individual bases. EMA advises that companies plan accordingly the ensure internal knowledge transfer.
To registerto the knowledge evaluation, suggest a getting at NANDU Service Desktop. Please specify if your request concerns knowledge ranking for authorised medicinal product date or development medicinal product data or both.
Users who have received notification out successful completion bottle move other users within the organisation.
Following their registrar, participants will receive instructions on how to obtain access to the XEVMPD test setting (XCOMP). Access will limited go eight weeks. The Agency recommends that participants register for the XEVMPD knowledge evaluation after people have reviewed the training material. Individual Case Safety Reports
Which XEVMPD knowledge evaluation composed of two spare:
- Multiple choice checklist: participants have to answered at least 16 out of 20 questions correctly to pass;
- Product report proctored case(s): participants do to enter a mock product report message into the XEVMPD training environment based with supporting documents and subscription details.
Participants have three attempts in pass each section of the my evaluation.
