EudraVigilance training and support
The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the protection of public health in the European Union (EU).
EMA launched a new and improved version of EudraVigilance on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.
The Agency is delivering training courses on the enhanced EudraVigilance system to support national competent authorities (NCAs) and marketing authorisation holders (MAHs) in the European Economic Area (EEA). Training includes targeted e-learning and face-to-face trainings, webinars and information days.
EMA strongly recommends that both new and existing users complete all EudraVigilance and pharmacovigilance trainings recommended for their stakeholder group, as both the EudraVigilance system and pharmacovigilance guidelines are subject to updates.
In order to help users prepare for the changes resulting from the enhanced EudraVigilance system, EMA has developed a modular training curriculum:
On this page:
- Face-to-face training
- Support webinars
- Information days
- User guidance
- Eudravigilance online competency assessment for non-commercial sponsors
Face-to-face training courses on enhanced EudraVigilance system
|EudraVigilance training on electronic reporting of ICSRs in the ICH E2B(R3) format|
or those acting on their behalf, in charge of pharmacovigilance and drug safety with obligations to report suspected adverse reactions related to medicines
After successfully completing the course, participants will be able to:
|Available training dates in London|
|Available training dates in other locations||
In support of the launch of the new, improved version of the EudraVigilance system, EMA is organising a series of question-and-answer webinars for NCAs and MAHs in the EEA on operational aspects related to pharmacovigilance and EudraVigilance and to provide technical support in using the new functionalities and as part of the testing activities. The webinars take into account the most recent revisions of the Guideline on good pharmacovigilance practices (GVP) modules VI – Management and reporting of adverse reactions to medicinal products and IX – Signal Management.
The technical support webinars are also open to sponsors of clinical trials in the context of reporting of suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance Clinical Trial Module (EVCTM) and NCAs.
|National competent authorities|
Monthly, 2 hours
The webinars will cover:
Questions should be submitted to EV-Webinar-support-MAH-NCA@ema.europa.eu four days in advance of the webinars. Questions can also be raised during the webinars.
|Availability||No registration is needed. Places are restricted to 100 participants for each webinar and will be available on a first come, first served basis.|
|Marketing authorisation holders and sponsors of clinical trials – EudraVigilance and reporting of suspected adverse reactions in the pre- and post-authorisation phase|
The webinars will cover:
Questions should be submitted to EV-Webinar-support-MAH-NCA@ema.europa.eu 4 days in advance of the webinars. Questions can also be raised during the webinars.
|Availability||No registration is needed. Places are restricted to 200 participants for each webinar and will be available on a first come, first served basis.|
|Marketing authorisation holders – Signal management and EudraVigilance Data Analysis System (EVDAS)|
MAHs included in the signal management List of active substances and combinations involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders
The webinars will cover:
Questions should be emailed to EV-Webinar-support-MAH-NCA@ema.europa.eu four days in advance of the webinars writing 'MAHs EVDAS/Signal Management' in the email subject field.
Questions can also be raised during the webinars.
|Availability||No registration is needed. Places are restricted to 200 participants for each webinar and preference will be given to those participating in the signal management pilot.|
EMA is organising a series of information days for NCAs and MAHs to facilitate the launch of the new EudraVigilance system.
|EudraVigilance and signal management information days|
|Availability||Places are restricted to 120 participants|
User guidance and release notes
User guidance and release notes are available below:
- EudraVigilance EVWEB user manual (updated 26/07/18)
- EudraVigilance User Manual - Individual case safety report form
- Marketing authorisation holders' access via the EudraVigilance Data Analysis System (EVDAS) user manual (EV-G1a) (updated 14/05/2018)
- European database of suspected adverse reactions related to medicines: User manual for online access via the adrreports.eu portal
- XCOMP release note
- EudraVigilance release notes (updated 26/07/18)
- (published 19/12/2017)
EMA delivers training via e-learning videos, with additional support available in guidance documentation, user guides and webinars.
The Introduction to EMA's training offering (PhV-M0) module explains the courses required for each stakeholder group.
The table below lists the training modules, their codes names and their planned availability, where relevant. Presentations and video recordings of individual modules can be found at the bottom of this page. EMA will add further information on the modules as it becomes available.
|Pharmacovigilance||EudraVigilance||EudraVigilance IT systems|
|Introduction to EMA's training offering (PhV-M0)||How to register with EudraVigilance and EVDAS (EV-M1) (updated 26/07/18)||ISO ICSR standard implementation for IT system developers (IT-M1)|
|New EudraVigilance functionalities and the 2010 pharmacovigilance legislation (PhV-M1)||Introduction to EudraVigilance system components and system functionalities (EV-M2)||How to test ICSR submissions to EudraVigilance (IT-M2)|
Implementing ISO ICSR/ICH E2B(R3) (PhV-M2):
Key changes for pharmacovigilance (PhV-M2a)
Backwards and forwards conversion - impact on adverse reaction reporting (PhV-M2b)
Reporting of ICSRs by EudraVigilance users (EV-M3):
EV-Gateway, WEB-Trader and EV-Post functions (EV-M3a)
Create and send ICSRs using EVWEB part II (EV-M3e)
|ISO ICSR (E2B(R3)) system implementers workshop|
|How to prepare for simplified adverse drug reaction reporting in the European Union (PhV-M3)|
|Revised EudraVigilance access policy: impact on stakeholders (PhV-M4)||
EVDAS training (EV-M5):
|Revised Good Pharmacovigilance Practice (GVP) guidelines (PhV-M5): available from Q4 2018||Patients adverse drug reaction website, ADRreports.eu, (EV-M6)|
|Medical literature monitoring by EMA (EV-M7)|
Stakeholders can give feedback on the training materials through an online survey.
Eudravigilance online training and competency assessment for non-commercial sponsors
The online competency assessment process aims to help non-commercial sponsors of clinical trials who intend to submit ICSRs electronically for the first time to register with the EudraVigilance production environment after one user has successfully completed the assessment.
To be eligible, users must meet all of the following requirements:
- be from a 'new organisation' (non-commercial sponsor of clinical trials);
- be registered in XCOMP with the headquarters of their organisation;
- be from an organisation where no other user who has already completed the face-to-face training or the online competency assessment is registered with EudraVigilance.
Eligible users need to follow a series of steps to complete the online training:
- complete e-learning modules EV-M2, EV-M3a, EV-M3b, EV-M3c, EV-M3d and EV-M3e;
- the organisation and the user should register with the EudraVigilance XCOMP test environment to familiarise themselves with the system functionalities;
- perform the competency assessment by completing some exercises based on ICSR examples provided by EMA and enter them into the EudraVigilance XCOMP environment.
Users have three attempts to pass the assessment. If they fail, they need to take the face-to-face course before they can register with the EudraVigilance production environment.
Successful users will receive an e-mail notification from EMA. They can subsequently train other users within their organisation.
At least one user per organisation must have an email notification of successful completion of the competency assessment before the organisation can initiate electronic submission of ICSRs in the EudraVigilance production environment.
To apply, send a request to: firstname.lastname@example.org