EudraVigilance - EVWEB User Manual
26 July 2018EMA/501718/2018Information Management DivisionEudraVigilance - EVWEB User ManualVersion 1.530 Churchill Place Canary Wharf London E14 5EU United KingdomTelephone 44 (0)20 3660 6000 Facsimile 44 (0)20 3660 5555Send a question via our website www.ema.europa.eu/contactAn agency of the European Union European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Summary of changes:Section 2.1.1 Updated EVWEB services menu Added screenshot of select organizationEudraVigilance - EVWEB User ManualEMA/501718/2018Page 2/103
Table of ContentsTable of Contents . 31. Introduction . 51.1. About this User Manual . 51.2. Typographical Conventions . 51.3. EudraVigilance (EV) . 51.4. Main Functional Components of EudraVigilance . 61.4.1. EudraVigilance Database Management System (EVDBMS) . 61.4.2. MedDRA . 71.4.3. EudraVigilance ESTRI Gateway . 71.4.4. EVWEB . 81.5. Access to EudraVigilance & EVWEB . 101.5.1. Availability of the EVWEB application . 101.6. EVWEB Support. 111.7. Classification of product information and Level 2 A/B access . 122. EVWEB . 142.1. General Description . 142.1.1. Login . 142.1.2. User Interface Layout . 192.1.3. Session Time Out . 202.2. The Main Menu & Dynamic Buttons Set . 202.2.1. Main Menu . 202.2.2. Dynamic Buttons Set . 222.3. The Tree View Area . 222.4. The Active Area . 242.5. Interaction Between the Tree View & Active Area . 252.6. Data Entry . 262.6.1. Input Field Types . 262.6.2. Adding & Removing Tree View Area Sections/Sub-sections . 332.7. Search Methods . 352.7.1. Simple Query . 352.7.2. Advanced Query . 362.7.3. Advanced List Criteria Query . 402.8. Loading Data . 422.8.1. Load from the EVDBMS . 422.8.2. Load from a Local File . 472.8.3. Load from Within EVWEB . 492.9. Contextual Actions Menu . 493. ICSRs & Messages . 503.1. Contextual Help . 503.2. Creating Safety Messages & ICSRs . 513.3. Sending a Safety Message . 543.4. Creating an Acknowledgement Message . 54EudraVigilance - EVWEB User ManualEMA/501718/2018Page 3/103
3.5. Sending an Acknowledgement Message . 583.6. WEB Trader Screen Functions . 583.6.1. Handling Messages in WEB Trader . 603.6.2. Searching Messages in WEB Trader . 603.7. ICSRs Screen Functions . 623.7.1. Handling ICSRs & Safety Messages in the ICSRs Screen . 633.7.2. Searching ICSRs & Safety Messages in the ICSRs Screen . 643.8. Post Screen Functions . 653.9. Workspace Screen Functions. 663.9.1. Import Function . 673.9.2. Messages Tab . 693.9.3. Reports Tab . 703.9.4. Acknowledgements Tab . 713.10. Follow-Up & Add to Follow-Ups . 733.11. Export Functions. 743.11.1. Excel List Export . 743.11.2. Single-Item Export . 753.11.3. ICSR Download . 794. MedDRA . 874.1. Introduction. 874.2. MedDRA Structure . 884.3. MedDRA in EVWEB . 894.3.1. Performing a MedDRA Query . 904.3.2. MedDRA Query Results Management . 924.3.3. Primary SOCs . 944.3.4. LLT Current Status . 955. Administration Tools . 965.1. Re-Routing Rules (NCA Users) . 965.2. Rerouted ACKs (EMA Administrators) . 985.3. Field-Level Access (EMA Administrators) . 996. List of Abbreviations & Acronyms . 102EudraVigilance - EVWEB User ManualEMA/501718/2018Page 4/103
1. Introduction1.1. About this User ManualThis user manual is part of the official documentation prepared by the European Medicines Agency(EMA) to support the use of the EudraVigilance Web reporting tool EVWEB.The user manual consists of 5 chapters.Chapter 1 presents a comprehensive overview of the EVWEB application and should be read beforethe other chapters. It contains basic information regarding the structure, functions and use of EVWEB,which applies to all other sections and needs to be understood before moving on to the more advancedaspects of the system.Chapter 2 describes the creation and transmission of Safety and Acknowledgement messages, as wellas the functions available in the WEB Trader, ICSRs, Post and Workspace screens.Chapter 3 explains the integration of MedDRA in EVWEB and how to query the system for specificMedDRA terms.Chapter 4 provides an insight into the administration tools available in EVWEB.Chapter 5 lists the abbreviations and acronyms, along with their descriptions, introduced in this usermanual.1.2. Typographical ConventionsThe following typographical conventions have been used throughout this user manual:FormatDescription“Quoted text”Indicates user interface items such as buttons, text, or icon descriptions.Indicates EVWEB screens, for example Create and send ICSRs, WEBBoldTrader, ICSRs, Post, MedDRA, Workspace etc. Also denotes externaldocumentation titles referenced in this manual.Bold italicIndicates chapter/section titles and figure captions.CAPSIndicates keys you should press on your keyboard (i.e. SHIFT, TAB).Courier FontIndicates back end database items (i.e., schema and table names etc.)1.3. EudraVigilance (EV)EudraVigilance (EV) is the European data-processing network and database management system forthe exchange, processing and evaluation of Individual Case Safety Reports (ICSRs) related tomedicinal products authorised in the European Economic Area (EEA).EudraVigilance is a key component in supporting the EMA and its committees in the coordination of thesupervision, under practical conditions of use, of medicinal products which have been authorised withinthe European Community. EudraVigilance also provides advice on the measures to ensure the safe andeffective use of these products, in particular by evaluating and making available through apharmacovigilance database information on adverse reactions to the medicinal products in question.EudraVigilance provides the European Union (EU) with a data-processing network for the rapidtransmission of safety information, between the National Competent Authorities (NCAs) in the event ofEudraVigilance - EVWEB User ManualEMA/501718/2018Page 5/103
an alert relating to faulty manufacture, serious adverse reactions, and pharmacovigilance dataregarding medicinal products marketed in the community.In addition EudraVigilance supports the Clinical Trials Directive 2001/20/EC and regulation EU536/2014, through the EudraVigilance Clinical Trials Module (EVCTM). This module enables commercialand Non-Commercial Sponsors (NCSs) to report electronically Suspected Unexpected Serious AdverseReactions (SUSARs) that occur during clinical trials in accordance with the respective communityguidance.Please refer to the release notes for EudraVigilance (available on the EMA website:http://www.ema.europa.eu/) to get a list of the new functions and amendments to the existingsystem.This user manual deals with EudraVigilance version entering into production on the 22 November 2017.ICH E2B(R2) & E2B(R3) Standards1.3.1.1. ICH E2B(R2)The ICH E2B(R2) standard was introduced in 2001, and its aim was to migrate the industry from thethen traditional paper reporting style to a more efficient, electronic submission method. In order forthis to be possible, the E2B(R2) standard was designed in such a way as to improve theinteroperability between all concerned parties (i.e. regulatory authorities, pharmaceutical companiesand healthcare organisations), by standardising the data elements for the transmission of ICSRs.It should be noted that this standard is being phased out in favour of the newer, and more versatile,ICH E2B(R3). Still, the newly re-written EVWEB has retained the ability to import E2B(R2) data. This ispossible only through the Workspace import function (which allows importing, viewing/editing andsending; see section 3.9. Workspace Screen Functions) and the Post screen (which allows onlyimporting and sending; see section 3.8. Post Screen Functions).1.3.1.2. ICH E2B(R3)To make the ICH standards and the electronic case reporting more useful and compliant with changingpharmacovigilance practices, a new version referred to as ICH E2B(R3) was finalized in July 2013. ICHagreed to use the International Organization for Standardization (ISO) Individual Case Safety Report(ICSR) standard ISO EN 27953-2:2011 to meet the reporting requirements for E2B(R3).EVWEB, one of the functional components of EudraVigilance (see section 1.4.4. EVWEB), has beenre-written to support ICH E2B(R3) messages. Furthermore, additional updates and modifications havebeen applied to EVWEB and will be described in detail throughout this user manual.1.4. Main Functional Components of EudraVigilance1.4.1. EudraVigilance Database Management System (EVDBMS)The EudraVigilance Database Management System (EVDBMS) is the core component of the Europeanpharmacovigilance database. This web-based information system is designed to handle the safetyreport information in full compliance with the latest version of the International Conference onHarmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)specifications, featuring:EudraVigilance - EVWEB User ManualEMA/501718/2018Page 6/103
A fully integrated organisation and user management in the EudraVigilance communitysynchronised with the EudraVigilance Gateway profile management. A fully automated safety and message processing mechanism, using XML-based messaging,supporting both asynchronous data interchange and interactive transactions. A large reference pharmacovigilance database, which is built by importing and consolidating datafrom multiple sources, including information on medicinal products and adverse drug reactions. An extensive query and tracking/tracing capability, both from a scientific and administrativebusiness perspective.1.4.2. MedDRAMedDRA is the Medical Dictionary for Regulatory Activities. It was developed in the frame of the ICHM1 activities as a clinically validated international medical terminology for regulatory authorities, and ismaintained by the MedDRA Maintenance and Support Services Organisation (MSSO).MedDRA is used by regulators and the pharmaceutical industry for data entry, retrieval, evaluation andpresentation during all phases of the drug regulatory process (i.e. the pre- and post-authorisationphase). These processes include clinical studies, reports of spontaneous adverse reactions, events,regulatory submissions and regulated product information.1.4.3. EudraVigilance ESTRI GatewayThe EMA has implemented an electronic regulatory submission environment, the EudraVigilanceGateway, which follows the ICH M2 Gateway Recommendation for the Electronic Standards for theTransmission of Regulatory Information (ESTRI) Gateway.The purpose of the EudraVigilance Gateway is to operate a single, common, EEA-wide Gateway forreceiving regulatory submissions in a fully automated and secure way, including all aspects of privacy,authentication, integrity and non-repudiation of all transactions in pharmacovigilance.The EudraVigilance Gateway allows the pharmaceutical industry to report to a common reporting pointwithin the EEA, from where the transactions are re-routed to the concerned regulatory authorities. Itprovides the NCAs with a secure reporting mechanism to the pharmaceutical industry and to the EMA.The pharmaceutical industry, for example Marketing Authorization Holders (MAHs), is responsible forimplementing at least one of the supported ESTRI standards in order to ensure electroniccommunication with any EEA Regulatory Authority.The EudraVigilance Gateway supports two transmission modes: The Gateway transmission mode The WEB Trader transmission modeThe Gateway transmission mode refers to an organization that has a pharmacovigilance database thatis fully compliant with the applicable exchange standards, which permits the generation and receipt ofICSRs and the electronic transmission of them via a local gateway solution that meets the ICH M2recommendations and has been successfully tested and connected with the EudraVigilance Gateway.The WEB Trader transmission mode is an integrated component of the EudraVigilance Gatewaydesigned to support Small and Medium Size Enterprises (SMEs) or Regional Pharmacovigilance Centres(RPCs) to generate, send and receive ICSRs in a secure way, to any registered organisation within theEudraVigilance - EVWEB User ManualEMA/501718/2018Page 7/103
EudraVigilance community. This transmission mode is achieved through a specially developed internetbased reporting tool called EVWEB.The WEB Trader transmission mode is not applicable for NCAs that are connected through theEudraVigilance Gateway, but it may be selected as a transmission mode by RPCs, if applicable.1.4.4. EVWEBThe EVDBMS also provides interactive tools that allow the manual creation of Safety andAcknowledgement messages and their administration by a user via a web interface, called EVWEB.EVWEB can be used by any MAH or sponsor in the EEA. EVWEB is specifically designed for SMEs, whichdo not have a fully ICH E2B(R2) or E2B(R3) compliant pharmacovigilance system and/or ESTRIgateway in place. It provides the necessary tool to allow SMEs secure electronic reporting to the EMAand all NCAs in the EEA.EVWEB users must register with the EMA (see section 1.5. Access to EudraVigilance & EVWEB ofthis manual) and also follow EudraVigilance Training courses in order to familiarise themselves with thereporting facilities. Please visit the EudraVigilance training section of the EMA website(http://www.ema.europa.eu/) for up-to-date information on training courses.Access to EVWEB is personal and non-transferable for each user of each organisation. It is achievedthrough personal login, and password access keys can be obtained following registration withEudraVigilance.1.4.4.1. EVWEB’s Main Functions1.4.4.1.1. Create & Send Safety MessagesOne of the main functions of EVWEB is the ability to create and send ICSRs in relation to both the preand post-authorisation phases. WEB Trader users may use EVWEB for this purpose by compiling a newmessage containing one or more ICSRs using the specific screen of the application.EVWEB will automatically display the complete sections of the hierarchical structure of a typical ICSRgiving a user the opportunity to insert the information in the various f
EudraVigilance - EVWEB User Manual EMA/501718/2018 Page 5/103 1. Introduction 1.1. About this User Manual This user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool EVWEB.
Section 9 User manual of the eRMR for MAHs. The references to the ad-hoc eRMR have been deleted. The SDR criteria implemented in EV has been further emphasised. 17 Feb 2021 2.1 New section (9.10.) added to reflect the changes in the EVDAS outputs triggered by the Brexit implementation in EudraVigilance.
clinical trials and the WHO Uppsala Monitoring Centre . The goal is to ensure sustainability of EudraVigilance and associated activities in support of the EU pharmacovigilance activities and the protection of public health. In addition, the interaction with stakeholders as part of training and support as well as communication
This go-live plan outlines a set of detailed, sequenced tasks and activities required to lau nch the new EudraVigilance production system including the migration of more than 11 million Individual Case Safety Reports (ICSRs) and associated data and the decommissioning of the current (legacy)
The Agency's Identity and Access Management (IAM2) project aims to simplify the registration and management of . EudraVigilance. organisations and users from a business process and technology point of view. As part of the project, the Eu draVigilance platform will be integrated with two
rules and validation steps as described in the 'Note for Guidance EudraVigilance Human - Processing of Safety Messages and Individual Case Safety Reports (ICSRs)' (Doc. Ref. EMA/H/20665/04/Final, Revision 1). The following aspects are outlined in detail: The mandatory electronic reporting essentials
All training modules can be accessed via the EudraVigilance Training Page. EMA Website - Human Regulatory - Pharmacovigilance - EudraVigilance - Training page The e-learning modules are listed as clickable links in the table at the top of the webpage in a navigable table. PhV-M0 Introduction to training offering by the EMA
EMA Service Desk Portal EudraVigilance, Technical or application-specific queries EMA Service Desk portal: https://servicedesk.ema.europa.eu Urgent Technical Helpline Urgent technical or application-specific queries Urgent technical helpline: 44 (0)20 3660 8520 Ask EMA Pharmacovigilance-related or General Queries Ask EMA:
3 Draft as of 3 ebruary 2020 2019 Novel Coronavirus (2019-nCoV): Strategic Preparedness and Response Plan Epidemiological overview as of 1 February 2020 A total of 11953 confirmed cases of 2019‑nCoV have been reported worldwide (figure 2); Of the total cases reported, 11821 cases have been reported from China; In China, 60.5% of all cases since the start of the outbreak have been .
