EMA Frequently Asked Questions
Where do I find information on how to register for EudraVigilance?
Detailed information can be found on EMA.Europa.eu
How do I register for a EudraVigilance training course?
Where do I find training course dates?
Where do training courses taking place?
Training courses take place at the European Medicines Agency in London and in selected EU Member States.
Which discounts are available?
- 50% discount on the standard fee is available for participants from Government and Academia organisations (full time).
- 35% discount is available for participants from Small and medium sized enterprises (SME) that are registered with the EMA
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 the online exam taking place at the end of the training course, consisting of 2 sections:
- Part I – Multiple choice questionnaire
- Part II – Practical exam case performed 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 gain 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, a call can be made to the EMA service portal to request new credentials.
How do I gain access to the DIA online tool to perform the knowledge evaluation and have access to the training material?
Login details are included in the welcome email that each registered participant receives prior to the training course
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.
Has the EudraVigilance Veterinary system also changed?
No, the EudraVigilance Veterinary system is unchanged, only the EudraVigilance Human system was updated.
What is the role of DIA Europe in the training?
DIA was awarded a service concession contract by the European Medicines Agency for the organisation of a number of meetings and trainings during 2017-2020. In this role, DIA supports the EMA with their duty in capacity building of national competent authorities in working with the new EudraVigilance system and other training courses as well as in organising important Information Days.