Updated EudraVigilance – EVWEB User Manual

On 23 February 2022 the EMA published version 1.6 of the EVWEB web reporting tool.

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. The user manual consists of 5 chapters:

Chapter 1 presents a comprehensive overview of the EVWEB application and should be read before the 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 advanced aspects of the system.

Chapter 2 describes the creation and transmission of Safety and Acknowledgement messages, as well as 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 specific MedDRA 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 user manual.

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