EudraVigilance Training Programme

• Introduction and Available Training Courses
  
1. Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance
   
2. EudraVigilance - electronic reporting of ICSRs training
   
3. eXtended EV Medicinal Product Dictionary (XEVMPD)
   
• XEVMPD e-learning course
  
4. EV Data Analysis System (EVDAS) Training for National Competent Authorities
   
• Available Training Dates
  
• Training FAQs
  

Training FAQs

Q: What is the best option for me to take part in the XEVMPD training?



A: There are two ways to participate:

• Two day face-to-face training course (theoretical part and hands-on examples using the XEVMPD training environment)
  
• Follow the e-learning modules (theoretical part and hands-on examples using the XEVMPD training environment)
  
After successful completion of the XEVMPD knowledge evaluation, you will be provided with e-mail notification of successful completion of the XEVMPD knowledge evaluation by the Agency.

Q: What is the added value of the face-to-face XEVMPD course compared to the e-learning course?



A: During the face-to-face trainings, participants will interact directly with the trainers, EMA staff and fellow participants. Participants will be able to discuss real-life scenarios and examples and seek immediate advice. For two days, participants will be able to focus only on the training.



Q: Do I need to refresh my training if I previously attended (X)EVMPD training?



A:If you already attended an (X)EVMPD training course in the period of May 2004 to March 2012, your previously issued training certificate will allow you to start the electronic submission of information on authorised medicinal products/investigational medicinal products to the Agency and to use EVWEB.
However, users previously trained on the EVMPD are strongly advised to review the updated detailed guidance as regards recent changes, as well as the revised training material. Revised training information is available by the Agency, including an e-learning training course.



Q: We are using a 3rd Party Service Provider to submit XEVPRMs. Do they need to be trained on how to use the XEVMPD?



A: If you have made arrangements with a 3rd Party Service Provider to submit electronically information on authorised medicinal products (XEVPRMs), it is sufficient that a member of staff of the 3rd Party Service Provider has successfully completed a (X)EVMPD training.



Q: I performed the XEVMPD knowledge evaluation and received a notification of successful completion of the XEVMPD knowledge evaluation by e-mail. When can I expect the XEVMPD Training Certificate?



A: Training certificates are no longer requested. As stated on the EudraVigilance Registration web page (http://eudravigilance.ema.europa.eu/human/HowToRegister08.asp): "To register with EudraVigilance for the electronic submission of information on authorised medicinal products, organisations need to provide a notification of successful completion of the XEVMPD knowledge evaluation for at least one user." You should therefore attach this notification to the documents requested as part of the EudraVigilance registration process.



Q: I received login details for the XEVMPD Training environment to perform the knowledge evaluation. However, when I try to log in, I receive an error message that I cannot access this page. What should I do?



A: The provided login details are valid for 4 weeks. If you cannot access the XEVMPD Training environment, we suggest that you contact your IT department to check for restrictions on your computer.

For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu


Q: What is the fee for the XEVMDP e-learning knowledge evaluation?



A: The XEVMPD e-learning modules are available cost-free and the XEVMPD knowledge evaluation is also free of charge.



Q: When can I perform the XEVMPD e-learning knowledge evaluation?  



A: Once you review the published XEVMPD e-learning modules and the available training material, you can register for the XEVMPD knowledge evaluation by sending an e-mail with your registration request to evtraining@ema.europa.eu.  You will then receive all the necessary documents and instructions on how to perform the XEVMPD knowledge evaluation, including your login details to the XEVMPD Training Environment.



Q: I am performing the XEVMPD knowledge evaluation and cannot find some of the information I need in the XEVMPD training environment (organisation, I'm supposed to use in my product entry, QPPV, substance). What should I do?



A: Generally, if data is missing in the XEVMPD, users are requested to insert it. The approach should be the same when performing the XEVMPD knowledge evaluation in the XEVMPD Training environment. Please see your XEVMPD Training User Manual or the e-learning videos to see how to insert an organisation, QPPV or substance.

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Last update: Wednesday, 6 July 2016.