EudraVigilance training

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The European Medicines Agency (EMA) has developed a modular training course to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance.

At least one user from each national competent authority, marketing authorisation holder or sponsor of clinical trials in the European Economic Area (EEA) should complete the training to ensure the information collected in EudraVigilance is of the highest quality and integrity.

Users who have successfully completed the currently available EudraVigilance training courses and the subsequent registration process will be able to start the electronic submission of individual case safety reports (ICSRs) and ICSR acknowledgements to meet their reporting obligations in relation to pharmacovigilance or clinical trials authorised in the EEA.

Current training courses

EudraVigilance training on electronic reporting of ICSRs in the EEA

Target audience
  • Marketing authorisation holders and clinical trial sponsors 
  • All prospective users of EudraVigilance - attendees who pass the final test will be able to register with EudraVigilance and report ICSRs to EMA or national competent authorities
Duration 3 days
Learning outcomes

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

  • apply ICH rules to safety reporting;
  • describe the registration process with EudraVigilance;
  • understand the concepts of electronic transmission of ICSRs;
  • describe the EudraVigilance Gateway;
  • describe the Webtrader functions;
  • explain the reporting processes for fully-automated organisations, post-function users, and EVWEB users;
  • create, validate and send safety messages;
  • create, validate and send follow-up reports, nullification reports, literature reports, parent-child reports and study reports, reports with medical and drug history;
  • apply EudraVigilance business rules;
  • create and send acknowledgments of received ICSR messages;
  • search and download safety reports;
  • search and view MedDRA through EVWEB.
Available training dates

EudraVigilance Data Analysis System (EVDAS) training for national competent authorities in EEA Member States

Target audiencePharmacovigilance experts and assessors at national competent authorities in EEA Member States
Duration 2 days
Learning outcomes

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

  • get a detailed overview of available EVDAS queries;
  • see how EVDAS / electronic reaction monitoring reports (eRMRs) can support signal detection and other pharmacovigilance activities such as Periodic Safety Update Report (PSUR) assessment;
  • learn how to review eRMRs;
  • understand disproportionality/statistical signal detection.
Available training dates
  • 15-16 March 2017, London, UK

This training course is only available for staff of the National Competent Authorities in the network.

Registration is possible via the EU Network Training Centre Learning Management System (LMS). If you have not yet registered an account, click on the ‘New user’ link on the login page and submit the registration form.

For more information or questions, please contact networktraining@ema.europa.eu

New training curriculum  

Over the course of 2016 and 2017, the Agency will release a set of training modules focusing on pharmacovigilance, EudraVigilance and IT related matters.

EMA has developed this new training curriculum to prepare stakeholders for the changes introduced by the 2010 pharmacovigilance legislation regarding adverse reaction reporting and signal detection:

The modules will also cover the planned enhanced EudraVigilance functionalities. 

As both the EudraVigilance system and the pharmacovigilance guidelines will be updated, EMA recommends that both new and existing users undertake all EudraVigilance trainings recommended for their stakeholder group.

The Introduction to EMA’s training offering (PhV-M0) module explains which courses are required for each stakeholder group.

Training will be delivered mainly through e-learning videos, with additional support available through guidance documentation, user guides and webinar sessions

Stakeholders can give feedback on the training materials through an online survey. EMA will continue to offer EVDAS training for national competent authorities and information days as classroom training. 


 

When to start training

Stakeholders are advised to start their training around six months before EMA implements the new EudraVigilance functionalities, and to plan regular refresher training sessions in the run-up to implementation. For more information on the implementation plan, see EudraVigilance.

Stakeholders are also advised to focus on the pharmacovigilance training modules, which will address the revision of the guidelines on Good Pharmacovigilance Practices (GVP) and its impact on operational and procedural aspects in relation to electronic reporting:

The below table lists the new training modules and their planned launch. EMA will add further information on the courses as it becomes available. 

PharmacovigilanceEudraVigilanceEudraVigilance IT systems
Introduction to EMA’s training offering (PhV-M0): now available, details belowHow to register with EudraVigilance and EVDAS (EV-M1): available from Q1 2017 (updated)ISO ICSR standard implementation for IT system developers (IT-M1): now available, details below
New EudraVigilance functionalities and the 2010 pharmacovigilance legislation (PhV-M1): now available, details belowIntroduction to EudraVigilance system components and system functionalities (EV-M2): now available, details belowHow to test ICSR submissions to EudraVigilance (IT-M2): available from Q1 2017

Implementing ISO ICSR/ICH E2B(R3) (PhV-M2): 

PhV-M2a now available, details below
PhV-M2b now available, details below

Reporting of ICSRs by EudraVigilance users (EV-M3):

EV-M3a now available, details below
EV-M3b now available, details below
EV-M3c now available, details below
EV-M3d now available, details below

ISO ICSR (E2B(R3)) system implementers workshop: now available, details below
How to prepare for simplified adverse drug reaction reporting in the European Union (PhV-M3): now available, details below  
Revised EudraVigilance access policy: impact on stakeholders (PhV-M4):  now available, details below

EVDAS training (EV-M5):

EV-M5a now available, details below
EV-M5b now available, details below

 
Revised Good Pharmacovigilance Practice (GVP) guidelines (PhV-M5): available from Q1 2017Patients adverse drug reaction website, ADRreports.eu, (EV-M6): now available, details below 
 Medical literature monitoring by EMA (EV-M7): available from Q1 2017 (updated) 

Table of contents


Pharmacovigilance

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Introduction to EMA’s training offering (PhV-M0)
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;
  • apprehend 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
New EudraVigilance functionalities and the 2010 pharmacovigilance legislation (PhV-M1)
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
Implementing ISO ICSR/ICH E2B(R3): Impact on adverse reaction reporting (PhV-M2a)
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
Implementing ISO ICSR/ICH E2B(R3): Backwards and forwards conversion (PhV-M2b)
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
How to prepare for simplified adverse drug reaction reporting in the European Union (PhV-M3)
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

Revised EudraVigilance access policy: impact on stakeholders (PhV-M4)
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

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Introduction to EV system components and system functionalities (EV-M2)
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
EV Reporting process for users: EV Gateway, Web-Trader, EV-Post functions (EV-M3a)
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
EV Reporting process for users: Introduction to EVWEB (EV-M3b)
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

 

EV Reporting process for users: Export functions in EVWEB (EV-M3c)
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
EV Reporting process for users: Create and send ICSRs using EVWEB (EV-M3d)
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
EVDAS training for National Competent Authorities (EV-M5a)
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
EVDAS training for Marketing Authorisation Holders (EV-M5b)
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
ADRreports.eu portal (EV-M6)
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

EudraVigilance IT systems

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ISO ICSR standard implementation for IT system developers (IT-M1)
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
ISO ICSR (E2B(R3)) system implementers workshop
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. Documentation, resources and implementation milestones
  2. ISO ICSR implementation technical aspects (part 1)
  3. ISO ICSR implementation technical aspects (part 2) – HL7 V3 messaging
  4. Testing with EMA's new process and Q&A session
Availability

Video recordings of the workshop

 

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