EudraVigilance Components & Functionality Introduction
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1 EudraVigilance Components & Functionality Introduction Training Module EV-M2 This module outlines the EudraVigilance system components and system functionalities An agency of the European Union
2 Content Summary Introduction EudraVigilance System Components Gateway Organisation and User Management Database Management System Data Analysis System ADR Reports Portal 1
3 Introduction: Target Audience Target audience for this training module: National Competent Authorities in the European Economic Area (EEA) Marketing authorisation holders (MAHs) Commercial and non-commercial sponsors of clinical trials (Sponsors) 2
4 Introduction: Context The intention of this training module is to provide an understanding of the technical components that together provide all the functionalities of the system, from a users perspective. It will also provide an overview of how all these components interact together. The knowledge gained from this module will provide the foundational basis for the subsequent training modules that will focus more on specific technical components. 3
5 Introduction: Learning Objectives At the end of module EV-M2 you should be able to: Understand the key technical Components & Functionalities of the EudraVigilance system Recognise which of these Components & Functionalities are relevant from the perspective of an NCA, MAH, Sponsor of clinical trails 4
6 EudraVigilance System Components EVWEB EudraVigilance WEB Reporting Application creation submission query MAH download (*EVPM) NCA rerouting EV Gateway EudraVigilance Gateway EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Adrreports.eu portal Adverse Drug Reaction Reporting portal Recoding Duplicate Detection MedDRA & Standard Terminology Medicinal Products (Art 57 Database/XEVMPD) EV Organisation & User Management 5
7 EudraVigilance Gateway Secures electronic submissions within the EEA EV Gateway EudraVigilance Gateway Enables the exchange of ICH s & acknowledgment Messages Provides Non- Repudiation through Message Disposition Notification (MDN) 6
8 EudraVigilance System Components EVWEB EudraVigilance WEB Reporting Application creation submission query MAH download (*EVPM) NCA rerouting EV Gateway EudraVigilance Gateway EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Adrreports.eu portal Adverse Drug Reaction Reporting portal Recoding Duplicate Detection MedDRA & Standard Terminology Medicinal Products (Art 57 Database/XEVMPD) EV Organisation & User Management 7
9 EudraVigilance Organisation and User Management Registration of EudraVigilance stakeholder organisations including their organisation s Identifier Organisation transmission mode Registration of Users within an organisation Assignment of user access rights EV Organisation & User Management 8
10 EudraVigilance Organisation and User Management EV Organisation & User Management Users will be able to access the different parts of the EudraVigilance system depending on the access rights assigned to them At the time of registration of an organisation a user(s) within that organisation will be assigned the role of administrator which will enable them to: Create new users Remove existing users Set access permissions for users 9
11 EudraVigilance System Components EVWEB EudraVigilance WEB Reporting Application creation submission query MAH download (*EVPM) NCA rerouting EV Gateway EudraVigilance Gateway EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Adrreports.eu portal Adverse Drug Reaction Reporting portal Recoding Duplicate Detection MedDRA & Standard Terminology Medicinal Products (Art 57 Database/XEVMPD) EV Organisation & User Management 10
12 The EudraVigilance Database Management System EVWEB EudraVigilance WEB Reporting Application creation MAH download (*EVPM) submission query NCA rerouting EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) Recoding Duplicate Detection The EudraVigilance Database Management System (EVDBMS) is the core component of the European pharmacovigilance database. It includes a fully automated safety and message processing mechanism, in accordance with ISO :2011 and ICH E2B(R2) specifications It also includes administrative systems for managing the data held in the database Provides access to data in accordance with the EudraVigilance Access policy 11
13 EVWEB Application EVWEB EudraVigilance WEB Reporting Application creation MAH download (*EVPM) submission query NCA rerouting EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) Recoding Duplicate Detection EVWEB is a web application that is specifically designed for organisations that do not have a pharmacovigilance system for electronically reporting s to the relevant regulatory authority. Using the Online EVWEB forms users can create and send electronic s in compliance with the required standards. EVWEB enables the receiving of safety and acknowledgement messages. The EVPOST function in EVWEB allows organisations to Post valid electronic s files created by their own pharmacovigilance system without having a local gateway installed. 12
14 The EudraVigilance Database EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) The EudraVigilance Database is divided into two parts: Recoding Duplicate Detection The EudraVigilance Post-Authorisation Module (EVPM), For s related to spontaneous reports and reports from non-interventional studies The EudraVigilance Clinical Trial Module (EVCTM), For s related to reports on suspected unexpected serious adverse reactions (SUSARs) that occur in the frame of interventional studies 13
15 The EudraVigilance Database Management System EVWEB EudraVigilance WEB Reporting Application creation MAH download (*EVPM) EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) Recoding submission Duplicate Detection query NCA rerouting The Re-routing component allows National Competent Authorities to choose which s should be re-routed to them following the implementation of simplified reporting The Download component allows Marketing Authorisation Holders to download s in accordance with the EudraVigilance Access policy The Duplication Detection component allows the EMA to manage duplicated s within EudraVigilance through the creation of master cases The Recoding component allows the EMA to recode verbatim drug and substance information reported in s against Art57 medicinal product information 14
16 EudraVigilance System Components EVWEB EudraVigilance WEB Reporting Application creation submission query MAH download (*EVPM) NCA rerouting EV Gateway EudraVigilance Gateway EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Adrreports.eu portal Adverse Drug Reaction Reporting portal Recoding Duplicate Detection MedDRA & Standard Terminology Medicinal Products (Art 57 Database/XEVMPD) EV Organisation & User Management 15
17 EudraVigilance Data Analysis System The EudraVigilance Data Analysis System has been designed to allow users to analyse safety data collected in EudraVigilance It enables better-informed decisions about the safety profile of medicinal products ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis It provides a range of analytical tools: from measuring reporting compliance for regulatory purposes, to pharmacovigilance analyses (such as signal detection tools) 16
18 EudraVigilance Data Analysis System Data ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Organisations & Users xevmpd 17
19 EudraVigilance System Components EVWEB EudraVigilance WEB Reporting Application creation submission query MAH download (*EVPM) NCA rerouting EV Gateway EudraVigilance Gateway EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Adrreports.eu portal Adverse Drug Reaction Reporting portal Recoding Duplicate Detection MedDRA & Standard Terminology Medicinal Products (Art 57 Database/XEVMPD) EV Organisation & User Management 18
20 ADR Reports Portal ( Adrreports.eu portal Adverse Drug Reaction Reporting portal This website was launched by the European Medicines Agency in 2012 to provide public access to reports of suspected side effects inline with the EudraVigilance access policy. 19
21 EudraVigilance System Components EVWEB EudraVigilance WEB Reporting Application creation submission query MAH download (*EVPM) NCA rerouting EV Gateway EudraVigilance Gateway EVDBMS EudraVigilance Database Management System EudraVigilance postauthorisation module (EVPM) EudraVigilance clinical trials module (EVCTM) ETL Extraction, Transformation & Loading Process EVDAS EudraVigilance Data Warehouse and Analysis System Signal detection Data analysis Adrreports.eu portal Adverse Drug Reaction Reporting portal Recoding Duplicate Detection MedDRA & Standard Terminology Medicinal Products (Art 57 Database/XEVMPD) EV Organisation & User Management 20
22 EudraVigilance System Components In this training module we have examined the Components & Functionality of the EudraVigilance system Gateway Organisation and User Management Database Management System EVWEB Download Data Analysis System ADR Reports Portal 21
23 Feedback Please provide us with feedback on this E-learning module and any attendant guidance documents you have viewed by taking the EMA training survey. The survey is accessible via this link. 22
24 Thank you for your attention Further information/ Contact information European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us
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