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.

TrainingIn 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 courses on enhanced EudraVigilance system

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

or those acting on their behalf, in charge of pharmacovigilance and drug safety with obligations to report suspected adverse reactions related to medicines

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 in London
Available training dates in other locations

Support webinars

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
Target audience
  • Experts with obligations to report suspected adverse reactions related to medicines and to perform signal management;
  • Users of EudraVigilance (EVWEB and EVDAS);
  • IT experts responsible for adaptations of national pharmacovigilance/safety system
Duration

Monthly, 2 hours

Content

The webinars will cover:

  • operation of pharmacovigilance with main focus on the latest revision of GVP Modules VI - Management and reporting of adverse reactions to medicinal products;
  • procedural and implementation planning questions related to the launch of the new EudraVigilance System, including the use of the new ICH E2B(R3) Individual Case Safety Report (ICSR) format, the use of EVDAS for signal detection, the process and tools to register new organisations and users with EMA's Account Management portal and Organisation Management Service (OMS), and EudraVigilance access policy;
  • IT system implementation/upgrade, pharmacovigilance/safety databases and testing performed with the new EudraVigilance test environment (XCOMP).

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.
Dates
  • 26 July 2018 14:00-16:00 UK Time
  • 27 September 2018 14:00-16:00 UK Time
  • 18 October 2018 14:00-16:00 UK Time
  • 22 November 14:00-16:00 UK Time
  • 13 December 2018 14:00-16:00 UK Time

PDF iconJoining instructions

Marketing authorisation holders and sponsors of clinical trialsEudraVigilance and reporting of suspected adverse reactions in the pre- and post-authorisation phase
Target audience
Duration

2 hours

Content

The webinars will cover:

  • operation of pharmacovigilance focusing on the latest revision of GVP Modules VI - Management and reporting of adverse reactions to medicinal products, reporting of suspected unexpected serious adverse reactions (SUSARs) in accordance with current legislation and guidance;
  • procedural and implementation questions related to the EudraVigilance system, including the use of the new ICH E2B(R3) Individual Case Safety Report (ICSR) format, the process and tools to register new organisations and users with EMA's Account Management portal and Organisation Management Service (OMS), and EudraVigilance access policy.
  • IT system implementation/upgrade, pharmacovigilance/safety databases and testing performed with the new EudraVigilance test environment (XCOMP).

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.

Dates

  • 25 July 2018 14:00-16:00 UK Time
  • 30 August 2018 14:00-16:00 UK Time
  • 26 September 2018 14:00-16:00 UK Time (includes user management/registration system live demo)
  • 17 October 2018 14:00-16:00 UK Time
  • 21 November 2018 14:00-16:00 UK Time
  • 12 December 2018 14:00-16:00 UK Time

Joining instructions

Marketing authorisation holders – Signal management and EudraVigilance Data Analysis System (EVDAS)
Target audience

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

Duration

2 hours

Content

The webinars will cover:

  • MAH signal management pilot;
  • the implementation of GVP Module IX - Signal Management (Revision 1);
  • use of the EVDAS dashboard and tools to support EudraVigilance monitoring by MAHs.

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.
Dates
  • 13 June 2018 15:00-17:00 UK Time
  • 18 September 2018 15:00-17:00 UK Time
  • 20 November 2018 15:00-17:00 UK Time

PDF iconJoining instructions

Information days

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
Target audience
  • National competent authorities
  • Qualified Persons Responsible for Pharmacovigilance (QPPVs)
  • Individuals responsible for pharmacovigilance, safety databases or information management
  • IT system developers and data managers
Duration 1 day
Content
  • Update and overview of the Agency's preparations to launch the new EudraVigilance system
  • Platform for experts of NCAs and MAHs to share their change management planning experience and to raise regulatory, procedural or technical questions.
Availability Places are restricted to 120 participants
Dates
  • 7 December 2018

User guidance and release notes

User guidance and release notes are available below:

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.

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)
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 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.

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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

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Pharmacovigilance

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EudraVigilance IT systems

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