EMA 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.

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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:

EudraVigilance auditable requirement project: EudraVigilance training plan - Version 5

AdoptedReference Number: EMA/835422/2016

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Face-to-face training courses on enhanced EudraVigilance system

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

Target audience:

  • Users of EudraVigilance – new users and users already trained on working with EudraVigilance, including:
    • professionals from national competent authorities (NCAs);
    • marketing authorisation holders (MAHs);
    • sponsors of clinical trials;
  • 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

Virtual live hands-on training course on enhanced EudraVigilance system

Target audience:

  • Users of EudraVigilance – new users and users already trained on working with EudraVigilance, including:
    • professionals from national competent authorities (NCAs);
    • marketing authorisation holders (MAHs);
    • sponsors of clinical trials;
  • or those acting on their behalf, in charge of pharmacovigilance and drug safety with obligations to report suspected adverse reactions related to medicines

Duration: 5 x 0.5 day

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:

Virtual live hands-on training course for clinical trial sponsors

Target audience:

  • Users who have to report suspected unexpected serious adverse reactions (SUSAR) originated in the context of clinical trials, using the ISO / ECH E2B(R3) ICSR format
  • Sponsors of clinical trials from EVWEB user organisations

Duration: 3 x 0.5 day

Learning outcomes:

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

  • apply the ISO / ICH E2B(R3) format and rules to safety reporting based on practical examples for:
    • initial SUSARs and follow-up reports;
    • amendment and nullification reports;
    • parent-child cases; 
    • reports from interventional studies.
  • understand how to use EVWEB to create, send and access ICSRs and acknowledgments;
  • query, view, browse and download ICSRs.

Available training dates:

Information days

EMA is organising a series of information days to update NCAs and MAHs on activities related to the EudraVigilance system.

User guidance and release notes

EudraVigilance - EVWEB user manual

Reference Number: EMA/501718/2018 Version 1.7

English (EN) (6.41 MB - PDF)

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EudraVigilance user manual - Individual case safety report form - Version 1.1

Reference Number: EMA/249220/2016

English (EN) (557.95 KB - PDF)

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EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal - Version 2.0

Reference Number: EMA/754608/2016Summary:

This manual provides instructions on how to use the adrreports.eu portal to obtain access in EudraVigilance to reports of suspected adverse reactions (also referred to as undesirable effects or side effects) related to medicines.

English (EN) (1017.67 KB - PDF)

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EudraVigilance XCOMP release - EudraVigilance web application (EVWEB) version 3.0

Reference Number: EMA/629617/2017

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EudraVigilance release notes v.1.22

Reference Number: EMA/257535/2019Summary:

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

English (EN) (167.01 KB - PDF)

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European database of suspected adverse drug reaction reports’ website (www.adrreports.eu): release notes v.1.0

Reference Number: EMA/833629/2017Summary:

European database of suspected adverse drug reaction reports’ website (www.adrreports.eu): Release notes v.1.0

English (EN) (96.93 KB - PDF)

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EudraVigilance user manual for marketing authorisation holders

Reference Number: EMA/167839/2016 Version 2.1Summary:

Marketing Authorisation Holders - EudraVigilance access via the EudraVigilance Data Analysis System

English (EN) (3.16 MB - PDF)

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E-learning

EMA delivers training via e-learning videos, with additional support available in guidance documentation, user guides and webinars.

This introduction module explains the courses required for each stakeholder group.

Presentation - Introduction to training offering by European Medicines Agency: Training module PhV-M0 

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)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)
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) 

Notes: Some EMA training modules contain a quiz to help users test their knowledge at the end. These can be found within the training module under 'Related information' or 'Related content'.

Users wishing to view their quiz results should:

  • Click 'Submit' on completing the quiz and take note of the Contribution ID code displayed on their screen

  • Go to the EU Survey home page and click on 'Download contribution'

  • Enter their Contribution ID code and email address when prompted

They will then receive an email containing their quiz results. For help and support, see: EU survey support

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 an organisation registering in EudraVigilance for the first time (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 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 active 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

Target audience

Marketing authorisation holders, national competent authorities, sponsors of clinical trials and other interested parties

Duration20 minutes
Learning outcomes

This module provides an overview of the training offerings planned by the European Medicines Agency in the area of EudraVigilance, adverse drug reaction reporting and signal management.

At the end of module PhV-M0 you should be able to:

  • understand the training offerings by the EMA in the area of EudraVigilance, adverse drug reaction reporting, signal detection and management;
  • comprehend which training modules are relevant from the perspective of an national competent authority, marketing authorisation holder, sponsor of clinical trial and any other interested party;
  • describe where to access the supporting training materials.
Availability

Target audience

Marketing authorisation holders, national competent authorities in the EEA, sponsors of clinical trials and other interested parties

Duration1.5 hours
Learning outcomes

This module provides an overview of the pharmacovigilance legislation, which formed the basis for the new or enhanced EudraVigilance functionalities. It outlines what steps need to be taken to prepare for changes in business processes and provides an overview of the key milestones and timelines that should be adhere to.

At the end of module PhV-M1 you should be able to:

  • understand the legal requirements for changes of EudraVigilance;
  • describe the EudraVigilance System Implementation Plan;
  • apprehend the EudraVigilance System changes;
  • prepare for change management planning from the perspective of a national competent authority, a marketing authorisation holder and a sponsor of clinical trials;
  • understand where to obtain supporting information.
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities, sponsors of clinical trials and other interested parties

Duration1.5 hours
Learning outcomes

This module outlines the key principles of the ISO/ICH E2B(R3) ICSR standard and guideline and the impact on the collection, reporting and processing of adverse reactions reports.

It further highlights the specific EU requirements and the business rules to be adhered to when reports are submitted to EudraVigilance.

At the end of module PhV-M2a you should be able to:

  • refer to the origin of the development of the ISO ICSR standard and the ICH E2B(R3) Implementation Guide (IG);
  • describe the legal basis and the benefits for the use of the ISO ICSR/ICH E2B(R3) guideline;
  • recognise the impact on pharmacovigilance with the move from the ICH E2B(R2)guideline /M2 format to the E2B(R3) guideline/ISO ICSR standard;
  • describe changes to the business rules as outlined in the EU ICSR IG;
  • understand where to obtain supporting information.
Availability
Related content

Target audience

Marketing authorisation holders, national competent authorities, sponsors of clinical trials, research institutions, academia and other interested parties

Duration10 minutes
Learning outcomes

This module provides an overview of the conversion tools that stakeholders can use to convert ICSR files between the ISO/ICH E2B(R2) and ISO/ICH E2B(R3) data formats.

It further outlines how to use the ICH and EU backwards and forward conversion tools and the potential issues stakeholders should be conscious of following the conversion process.

At the end of module PhV-M2b you should be able to:

  • understand important background information regarding the ICH and EU backwards and forwards conversion tools;
  • perform a conversion using the conversion tool;
  • recognise issues that may be experienced after converting files.
Availability
Related content

Target audience

Marketing authorisation holders, national competent authorities in the EEA, WHO Uppsala Monitoring Centre and other interested parties

Duration30 minutes
Learning outcomes

This module provides an overview of the principles of the simplified adverse reaction reporting in the EU, how to prepare for this new process and how existing reporting processes should be adapted.

At the end of module PhV-M3 you should be able to:

  • describe the legal basis and the benefits for the simplification of the reporting of suspected adverse reactions based on the 2010 pharmacovigilance legislation;
  • recognise the current interim arrangements;
  • describe the new process of simplified reporting of suspected adverse reactions;
  • recognise important principles in the context of simplified reporting;
  • understand where to obtain supporting information and whom to contact in case of further questions.
Availability

Related information

Target audience

Marketing authorisation holders, national competent authorities and sponsors of clinical trials

Duration90 minutes
Learning outcomes

This module provides an overview of the main characteristics of the revised EudraVigilance Access Policy, how stakeholders obtain access to EudraVigilance data in support of their pharmacovigilance obligations. It also outlines the key requirements for personal data protection.

At the end of module PhV-M4 you should be able to:

  • Understand the legal background, scope and the key principles outlined in revision 2 of the EudraVigilance Access Policy;
  • Describe the levels of access provided to stakeholders based on six stakeholder groups;
  • Recognise how access will be granted to EudraVigilance data;
  • Describe the impact of obtaining access to EudraVigilance data;
  • Understand where to obtain supporting information.
Availability
  • Related information

EudraVigilance

Target audience

Marketing authorisation holders, national competent authorities and sponsors of clinical trials who need to register with EudraVigilance

Duration13 minutes
Learning outcomes

This module explains the steps and process to register with EudraVigilance and EVDAS and how to maintain the registered user information.

At the end of module EV-M1 you should be able to:

  • Understand who needs to register with EudraVigilance and EVDAS, and why;
  • Understand the new registration processes and tools by type of registration and stakeholder group;
  • Where to obtain supporting information
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities in the EEA, sponsors of clinical trials and other interested parties

Duration10 minutes
Learning outcomes

This module describes the EudraVigilance system components and system functionalities.

At the end of module EV-M2 you should be able to:

  • Understand the main technical system components and functionalities of the EudraVigilance system;
  • Recognise which of these components and functionalities are relevant and can be used from the perspective of a NCA, MAH, sponsor of clinical trials.
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities in the EEA, sponsors of clinical trials, research institutions, academia, and other interested parties

Duration10 minutes
Learning outcomes

This module describes the EudraVigilance Gateway, and how different EudraVigilance users interact can interact with the gateway in fulfilling their pharmacovigilance obligations.

At the end of module EV-M3a you should be able to:

  • Understand the functionality of the EudraVigilance Gateway;
  • Recognise how different EudraVigilance users can interact with the EudraVigilance Gateway, including the difference between Gateway organisations, WEB Trader Post Function users, and WEB Trader EVWEB users.
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities in the EEA, sponsors of clinical trials, research institutions, academia, and other interested parties

Duration15 minutes
Learning outcomes

This module provides instructions on accessing the EudraVigilance web reporting application (EVWEB) and provides an introduction to the functionality that can be accessed via the EVWEB application.

At the end of module EV-M3b you should be able to:

  • Understand the technical requirements for accessing the EVWEB application;
  • Understand how to login and logout of EVWEB;
  • Understand how to navigate between the sections of EVWEB.
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities in the EEA, sponsors of clinical trials, research institutions, academia, and other interested parties

Duration15 minutes
Learning outcomes

This module provides detailed information regarding the ICSR export tool available via the EudraVigilance web reporting application (EVWEB). It also outlines how the EudraVigilance Access Policy is implemented within the EVWEB application, and how the ICSR export tool can be used to obtain information from the database in accordance with this policy.

At the end of module EV-M3c you should be able to:

  • Understand the implementation of the Access Policy in EVWEB;
  • Understand how to use the ICSR export tool to obtain Level 2a and Level 2b access to ICSRs;
  • Understand how to use the ICSR export function to obtain Medical Literature Monitoring (MLM) cases;
  • Understand how to export previously sent ICSRs from your organisation.
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities in the EEA, sponsors of clinical trials, research institutions, academia, and other interested parties

Duration50 minutes
Learning outcomes

This module provides detailed information regarding the functionality available in the “create and send ICSRs” section of the EudraVigilance web reporting application (EVWEB). It also provides instructions on carrying out core EVWEB activities in this section, including the creation, validation and submission of ICSRs in EVWEB.

At the end of module EV-M3d you should be able to:

  • Understand the functionality available in the “create and send ICSRs” section of EVWEB;
  • Create an ICSR using EVWEB;
  • Validate and correct issues before sending an ICSR in EVWEB;
  • Send an ICSR.
Availability
Related information

Target audience

Marketing authorisation holders, national competent authorities in the EEA and sponsors of clinical trials who have to test the compliance of their database in order to submit ICSRs to EudraVigilance

Duration16 minutes
Learning outcomes

This module provides detailed information regarding the functionality available in the “create and send ICSRs” section of the EudraVigilance web reporting application (EVWEB). It builds on the EV-M3d training course and explains reporting for specific types of ICSR reports.

At the end of module EV-M3e you should be able to create the following types of report using EVWEB:

  • Nullifications and amendments;
  • Creating patient death reports;
  • Parent child report;
  • Observational studies;
  • Clinical trial SUSARs.
Availability
Related information

Target audience

National Competent Authorities (NCAs) in the EEA

Duration2 hours
Learning outcomes

This module provides information on the EudraVigilance Data Analysis System (EVDAS) functionalities available for NCA users in the EEA in support of their pharmacovigilance obligations. It also provides an overview of the changes introduced in EVDAS that have resulted from the transition to the new ICH E2B(R3) standard and specifies the key enhancements introduced in the new EVDAS catalogue of reports together with the new report's outputs.

At the end of module EV-M5a you should be able to:

  • Understand the role of EVDAS as part of the EudraVigilance system;
  • Be familiar with the new EVDAS catalogue of reports;
  • Be able to retrieve EV data using the EVDAS interface;
  • Understand the EVDAS changes triggered by the new ICH E2B (R3) standard;
  • Understand the main EVDAS reports and outputs.
Availability
Related information

Target audience

Marketing authorisation holders in the EEA

Duration1.5 hours
Learning outcomes

This module provides information on the EudraVigilance Data Analysis System (EVDAS) functionalities available for MAH users in the EEA in support of their pharmacovigilance obligations. It also provides an overview about how statistical signal detection is implemented in EudraVigilance.

At the end of module EV-M5b you should be able to:

  • Understand the access to EudraVigilance provided via EVDAS;
  • Be familiar with the EVDAS user interface;
  • Be able to retrieve electronic Reaction Monitoring Reports (eRMRs), Line Listings, and ICSR forms from EVDAS;
  • Understand the system functionalities for manipulating report's outputs;
  • Understand how signal detection is implemented in EudraVigilance;
  • Understand the outputs of the EVDAS reports.
Availability
Related information

Target audience

Patients and the general public, healthcare professionals, drug safety experts, academia

Duration20 minutes
Learning outcomes

This module provides an overview of the ADRreports.eu portal, which provides public access to reports of suspected side effects submitted to the EudraVigilance system by national medicines regulatory authorities and pharmaceutical companies that hold marketing authorisations for medicines in the European Economic Area. In addition to outlining the utility of the portal, this module also details the enhancements that will be made to the portal starting from November 2017.

At the end of module EV-M6 you should be able to:

  • understand the utility of the ADRreports.eu portal and what information it contains;
  • understand the enhancements to the portal that will be available from November 2017;
  • understand the potential uses of the portal;
  • understand where to obtain further information
Availability
Related information

Target audience

Marketing authorisation holders in the EEA

Duration14 minutes
Learning outcomes

This module provides an update on the changes to the medical literature monitoring service and an overview of improvements that have been implemented.

At the end of module EV-M7 you should be able to understand:

  • the new format of the MLM ICSRs;
  • how to access the MLM ICSRs using the new system;
  • why you may need to convert the format of MLM ICSRs;
  • changes to the reporting rules;
  • what will not change;
  • how to get more information.
Availability
Related information

EudraVigilance IT systems

Target audience

Marketing authorisation holders, national competent authorities, sponsors of clinical trials, research institutions, academia and other interested parties

Duration20 minutes
Learning outcomes

This module details the key points that IT system developers should be conscious of when implementing the ISO ICSR standard, and highlights documentation that can be used to assist in this process.

It further provides an overview of impending technical changes to EudraVigilance and how best to prepare for them, and details the relationships between key standards and implementation guides.

At the end of module IT-M1 you should be able to:

  • understand important background documentation related to individual case safety reports (ICSRs).
  • be aware of EU specific requirements for implementing the ISO ICSR standard.
  • Have an understanding of the issues that may be encountered when implementing the ISO ICSR standard.
Availability
Related content

Target audience

Marketing authorisation holders, national competent authorities and sponsors of clinical trials who have to test the interoperability of their local safety/pharmacovigilance database and EudraVigilance

Duration14 minutes
Learning outcomes

This module outlines the approach that should be taken by EudraVigilance stakeholders to undertake ICH E2B (R3) / (R2) compliance testing before moving into production with EudraVigilance.

At the end of module IT-M2 you should be able to:

  • register with EudraVigilance;
  • book a test slot for your database compliance testing;
  • understand what testing to do before testing with EMA;
  • download test ICH E2B (R3) or ICH E2B (R2) XMLs for testing;
  • request the activation of your EudraVigilance production profile.
Availability
Related content

 

Target audience

Marketing authorisation holders, national competent authorities and sponsors of clinical trials with an IT background

Duration5 hours
Learning outcomes

On 4 March 2016, the Agency held a workshop on the implementation of ISO ICSR 27953-2:2011 (ICH E2B(R3)) with representatives from software vendors, service providers and pharmacovigilance system implementers.

The aim was to openly discuss technical aspects of the implementation of ISO ICSR standards in Europe.

It consisted of four sessions:

  1. Presentation - Session 1 – Documentation, resources and implementation milestones
  2. Presentation - Session 2 – ISO ICSR Implementation technical aspects - Part 1
  3. ISO ICSR implementation technical aspects (part 2) – HL7 V3 messaging
  4. Presentation - Session 4 – Testing with EMA new process

     

Availability

Video recordings of the workshop

 

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