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EMA Frequently Asked Questions

  • My organisation (MAH) is currently not registered for electronic reporting with EudraVigilance and I am a new user. Do I have to attend a EudraVigilance training course?

    If you are an organisation that will initiate electronic reporting of ICSRs for the first time and your organisation is using EVWEB for reporting of ICSRs, you need to take into account that for the registration of your organisation, at least one person of your organisation needs to have successfully completed the EudraVigilance training

  • We are a non-commercial sponsor and not registered for electronic reporting with EudraVigilance. Do I have to attend a EudraVigilance face-to-face training course?

    Non-commercial sponsors that have not yet registered for electronic reporting with EudraVigilance and have no user that has previously followed the EudraVigilance training course, have the option to follow the free online training course published on the EMA website. Alternatively they can attend the face-to-face training course on the new EudraVigilance system.

  • My organisation is registered for electronic reporting with EudraVigilance. Do I have to attend a training course?

    If you are an organisation that is already registered for electronic reporting with EudraVigilance and there are new users, which will use EVWEB for reporting purposes, your organisation will need to decide if the new users are trained in-house by the person who was previously certified on the EV training course or if the new users should attend the face-to-face training courses. - For users, who have previously been trained on EudraVigilance, there will be e-learning modules available, which they can follow to familiarise with the new ICH E2B(R3) format and the new EVWEB interface/functionalities. Alternatively they can attend the face-to-face training course on the new EudraVigilance system.

  • Will EudraVigilance Veterinary system also change?

    No, only the EudraVigilance Human system is changing. The EVVET remains unchanged.

  • Where do I find information on how to register to EudraVigilance?

    Detailed information can be found on the EMA website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000687.jsp&mid=WC0b01ac0580a69262

  • How do I register to a EudraVigilance training course?

    Registration can be done online on the DIA website www.diaglobal.org/emaevents (credit card payment only) or by sending DIA the registration form via fax or email.

  • Where do I find training course dates?

    Training course dates can be found on the EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000162.jsp&mid=WC0b01ac0580a1a1fb and DIA website: www.diaglobal.org/emaevents

  • Where do training courses taking place?

    Training courses take place at the European Medicines Agency in London or in selected EU Member States

  • Which discounts are available

    50% discount on the standard fee is available for participants from Government and Academia (full time). 35% discount is available for participants from Small and medium sized enterprises (SME) that are registered with the EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000059.jsp&mid=WC0b01ac05800240cc

  • What is included in the training course registration fee?

    The registration fee includes IT equipment, refreshments and lunches as well as online access to the training course material, knowledge evaluation & certificate of attendance. Material for the practical exercises are provided as print-outs.

  • What is the EudraVigilance knowledge evaluation?

    This is an exam that takes place at the end of the training course in an online tool. It consists of 2 parts: PartI – Multiple choice, Part II – practical exam in the EudraVigilance training site. Participants have 3 attempts to pass each part. Passing score is 80%.

  • Is it mandatory to do the EudraVigilance knowledge evaluation?

    At least one user per organisation should follow the training. A notification of successful completion is required to be able to register as a user to EudraVigilance.

  • How do I get access to the training site of the EudraVigilance database?

    Participants of face-to-face courses receive personal logins by the trainer to access the EudraVigilance training site. These logins are valid for around 8 weeks. They cannot be extended. In case of need, new logins can be requested through the EMA service portal: https://servicedesk.ema.europa.eu/jira/servicedesk/customer/user/login?nokerberos&destination=portals

  • How do I get access to the DIA online tool to perform the knowledge evaluation

    Login details are included in the welcome email that each registered participant receives shortly before the training course

  • How do I receive the results of the knowledge evaluation?

    Participants receive a notification email from the EMA confirming the outcome of their knowledge evaluation approximately 2-3 weeks after the training course.

  • What is the role of DIA Europe in the training?

    DIA Europe is acting as a conference organiser on behalf of the European Medicines Agency, taking care of all administrative and logistic tasks.


View EMA Course Catalog

View EMA Conference Catalog