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.

TrainingThe 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:

Face-to-face training courses on enhanced EudraVigilance system

EudraVigilance training on electronic reporting of ICSRs in the ICH E2B(R3) format

Target audience:

Duration: 3 days

Learning outcomes:

After successfully completing the course, participants will be able to:

  • describe the EudraVigilance System components;
  • apply ISO/ICH E2B(R3) rules to safety reporting based on practical examples for initial and follow-up reports, amendment and nullification reports, literature and parent-child cases, and reports from studies;
  • understand how to use EVWEB to create, send and access ICSRs and acknowledgments;
  • describe the principles of EVDAS and access by MAHs to use electronic Reaction Monitoring Reports (e-RMRs), line listings and ICSR forms;
  • query, view, browse and download ICSRs using the EudraVigilance ICSR Download Functionality, which provides access by MAHs to ICSRs submitted by NCAs in the EEA

Available training dates:

Information days

EMA is organising a series of information days for NCAs and MAHs to facilitate the launch of the new EudraVigilance system.

User guidance and release notes

E-learning

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.

PharmacovigilanceEudraVigilanceEudraVigilance 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)
Introduction to EVWEB (EV-M3b) (updated 26/07/18)
Export functions in EVWEB (EV-M3c)
Create and send ICSRs using EVWEB part I (EV-M3d)

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):

EV-M5a
EV-M5b

 
Revised Good Pharmacovigilance Practice (GVP) guidelines (PhV-M5): available from Q4 2018Patients 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: evtraining@ema.europa.eu

Pharmacovigilance

EudraVigilance

EudraVigilance IT systems

How useful was this page?

Add your rating
Average
7 ratings
2 ratings
1 rating
1 rating
5 ratings