EudraVigilance training and support

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

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.

• Video recording of the module
• Introduction to training offering by EMA

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

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.

• Video recording of the module
• Implementing ISO ICSR/ICH E2B(R3): Key changes for pharmacovigilance

• Module quiz
• EudraVigilance change management

• Implementation of the ISO IDMP standards

• ICH E2B(R3) Implementation Guide
• EU ICSR Implementation Guide

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

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.

• Video recording of the module
• Implementing ISO ICSR/ICH E2B(R3): Key changes for pharmacovigilance

• EudraVigilance change management
• ICH E2B(R3) Implementation Guide
• EU ICSR Implementation Guide

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

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

• Video recording of the module
• How to register with EudraVigilance and EVDAS (EV-M1) (updated 26/07/18)

• EudraVigilance: how to register

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

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.

• Video recordings of the module
• EudraVigilance components & Functionality introduction

• Module quiz
• EudraVigilance system overview

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

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.

• Video recordings of the module
• EV Reporting process for users: EV Gateway, WEB-Trader, EV-Post functions

• EudraVigilance system overview

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

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.

• Video recordings of the module
• EV Reporting process for users: Introduction to EVWEB (updated 26/07/18)

• EudraVigilance system overview

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

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.

• Video recordings of the module
• EV Reporting process for users: Export functions in EVWEB

• EudraVigilance system overview

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

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.

• Video recordings of the module
• EV Reporting process for users: Create and send ICSRs using EVWEB part I (EV-M3d)

• EudraVigilance system overview

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

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.

• Video recordings of the module
• EV Reporting process for users: Create and send ICSRs using EVWEB part II (EV-M3e)

• EudraVigilance system overview
• EV Reporting process for users: Create and send ICSRs using EVWEB part I (EV-M3d)

National Competent Authorities (NCAs) in the EEA

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.

• Video recordings of the module
• EVDAS training for National Competent Authorities

• EudraVigilance system overview
• ICH E2B(R3) Implementation Guide
• EU ICSR Implementation Guide
• Good pharmacovigilance practices
• Module quiz

Marketing authorisation holders in the EEA

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.

• Video recordings of the module
• EVDAS training for Marketing Authorisation Holders
• MAH eRMR example
• Line listing example

• EudraVigilance system overview
• Good pharmacovigilance practices
• Revised EudraVigilance Access Policy
• Revised EudraVigilance stakeholder change management plan
• Module quiz

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

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

• Video recording of the module
• ADRreports.eu portal training module

• ADRreports.eu portal
• Module quiz
• Revised EudraVigilance Access Policy

Marketing authorisation holders in the EEA

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.

• Video recording of the module
• Medical literature monitoring by EMA - changes to the service

• Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance
• Impact on adverse reaction reporting (PhV-M2a)
• EV Reporting process for users: Export functions in EVWEB (EV-M3c)