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
  

EudraVigilance Training Programme

• Training FAQs
  

EudraVigilance Training Programme

In order to start:
• The electronic transmission of Individual Case Safety Reports (ICSRs) (Safety messages) and ICSR acknowledgements in the context of clinical trials and post-authorisation of medicinal products

and / or

• The electronic submission of information on authorised medicinal products in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 by means of the Extended EudraVigilance Medicinal Product Report Messages (XEVPRMs) and XEVPRM acknowledgements

and / or

• The electronic submission of information on Investigational Medicinal Products (IMPs) in accordance with 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') by means of the Extended EudraVigilance Medicinal Product Report Messages (XEVPRMs) and XEVPRM acknowledgements

MAHs or Sponsors need to register with the Agency. This is to ensure that proper privacy and security measures are in place and that the principles of integrity, accountability and availability of data are adhered to.

Registration is based on the existing EudraVigilance registration process in operation since the implementation of the electronic transmission of individual case safety reports (ICSRs) and the establishment of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

At least one user from each MAH or Sponsor should receive training. This is to ensure the quality of data submitted to the EudraVigilance database.

Users that have successfully completed the EudraVigilance training course offered by the Agency will be able to start the electronic submission of of Individual Case Safety Reports (ICSRs) (Safety messages) and ICSR acknowledgements in the context of clinical trials and post-authorisation of medicinal products after completing the necessary registration process.

Users that have successfully completed the XEVMPD training course offered by the Agency will be able to start the electronic submission of information on authorised medicinal products in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 by means of the Extended EudraVigilance Medicinal Product Report Messages (XEVPRMs) and XEVPRM acknowledgements after completing the necessary registration process.

Users that have successfully completed the XEVMPD training course offered by the Agency will be able to start the electronic submission of information on Investigational Medicinal Products (IMPs) in accordance with 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') by means of the Extended EudraVigilance Medicinal Product Report Messages (XEVPRMs) and XEVPRM acknowledgements after completing the necessary registration process.

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 that can be downloaded in the secure area of the EudraVigilance Website. The EudraVigilance training programme offers the following training courses:


1. Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) to Eudravigilance
   
2. EudraVigilance - electronic reporting of Individual Case Safety Reports (ICSRs)
   
3. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
   
4. EudraVigilance Data Analysis System (EVDAS) Training for National Competent Authorities
   

The training courses dates are accessible here.

These training courses are designed for:
• Small and Medium Size Enterprises (SMEs) and sponsors of clinical trials (sponsors) conducted in the EEA that use EVWEB for the electronic transmission of Individual Case Safety Reports (adverse reaction reporting).
  
• Marketing authorisation holders and sponsors that transmist electronically Individual Case Safety Reports (ICSRs) to EudraVigilance and Competent Authorities in Member States.
  
• Marketing authorisation holders that submit electronically to the Agency information on all medicinal products authorised in the European Union in accordance with Article 57(2), second subparagraph of Regulation (EC) 726/2004 using the XEVPRM format.
  
• Sponsors that enter information on investigational medicinal products in the eXtended EudraVigilance Medicinal Product Dictionary ('XEVMPD').
  
• National Competent Authorities that use EVDAS for signal detection and data analysis purposes.
  

For information about how to register with EudraVigilance please see here.

Any questions regarding the EudraVigilance Organisation and User Registration can be directed to eudravigilanceregistration@ema.europa.eu

For questions on training please visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
For urgent technical matters, telephone: +44 (0)20 3660 8520

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Last update: Tuesday, 5 July 2016.