Service for Working with Medicinal Products Safety Data. Frontend

Providing and exchanging information about adverse reactions to medical products is necessary in the process of identifying potential safety risks for medical products and improving the overall safety and effectiveness of drugs. Regulatory authorities worldwide require this type of data to be stored and exchanged in E2B(R3) format, which is a standardized data structure for reporting medical products’ adverse events and is part of the International Council for Harmonisation (ICH) E2B [6] guidelines, which provide a framework for the electronic submission of safety data in pharmacovigilance. The E2B(R3) data structure is based on XML and defines a specific format for exchanging adverse event information among different systems and stakeholders involved in drug safety reporting. In connection with the widespread usage of the E2B(R3) format, there is a need for the utilization of specialized software that facilitates smooth processing, storage and exchange of data in this particular format. This document is a graduation qualification thesis for the project “Service for Working with Medicinal Products Safety Data. Frontend” - the client side part of the service for working with individual case safety reports in E2B(R3) format. The remainder of the paper is organized as follows: In the "Introduction" section, the name of the program and the documents on which the development is based are specified. The "Purpose and subject area" section lists the purposes of the program, a brief description of the E2B(R3) format, and an analysis of analogs of the developed system. The "Technical Characteristics" section includes the following subsections: 1. Functional requirements for the developed system 2. Development tools and technical and software resources necessary for the system's operation 3. Organization of input and output data 4. Client side architecture of the program 5. Project structure How the interface works and how each functionality was implemented is described in the "Description of user interaction with the interface" section. The results of the work and the description of further development of the project concludes the paper.