Concept formulation for «automated expert workplace»

One of the principle ways of improving the process of the expert evaluation of medicines is the optimization of expert evaluation timing and creation the system, preventing the occurrence of errors. For this purpose the experts of the Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation are working on establishment of the concept of creating the information system that would meet all the requirements. The main objectives of the measures taken are the optimization of expert evaluations processes management, automation of manual operations associated with working activities of an expert, specific recommendations for the implementation of collection and storage of primary data, both obtained from analytical instruments and introduced by experts. The authors have considered general principles of «automated expert workplace» concept, the challenge of information technologies elaboration in the sphere of drug development, evaluation and circulation. The role of information systems at each stage of drug life cycle has been defined. A number of optimum approaches to organizing automated expert workplace have been identified

Формирование концепции «автоматизированного рабочего места эксперта»

One of the principle ways of improving the process of the expert evaluation of medicines is the optimization of expert evaluation timing and creation the system, preventing the occurrence of errors. For this purpose the experts of the Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation are working on establishment of the concept of creating the information system that would meet all the requirements. The main objectives of the measures taken are the optimization of expert evaluations processes management, automation of manual operations associated with working activities of an expert, specific recommendations for the implementation of collection and storage of primary data, both obtained from analytical instruments and introduced by experts. The authors have considered general principles of «automated expert workplace» concept, the challenge of information technologies elaboration in the sphere of drug development, evaluation and circulation. The role of information systems at each stage of drug life cycle has been defined. A number of optimum approaches to organizing automated expert workplace have been identified.Одним из основных направлений совершенствования процесса экспертизы лекарственных средств являются оптимизация сроков проведения экспертизы и создание системы, предотвращающей возникновение ошибок. С этой целью в ФГБУ «НЦЭСМП» Минздрава России проводится формирование концепции создания информационной системы, которая отвечала бы всем поставленным требованиям. Основными задачами проводимых работ являются оптимизация управления процессами экспертизы, автоматизация ручных операций, связанных с рабочей деятельностью эксперта, определение рекомендаций по выполнению сбора и хранения первичной информации, как получаемой с аналитических приборов, так и вводимой экспертами. Авторами рассмотрены общие принципы формирования концепции «Автоматизированное рабочее место эксперта», задача развития информационных технологий в сфере разработки, экспертизы и обращения лекарственных средств. Определена роль информационных систем на каждом этапе жизненного цикла лекарственного средства. Выделен ряд оптимальных подходов к организации автоматизированного рабочего места эксперта

Внедрение системы прослеживания образцов лекарственных средств

The article elaborates on a general overview of the tracing system and the possibilities of its implementation in the circulation of medicines. Moreover, it presents several variants of pharmaceutical production marking and the characteristics of those. The article touches upon the challenges of drug samples tracing system information support.В статье рассматривается общее представление о системе прослеживания и ее возможности внедрения в процессы обращения лекарственных средств. Также в статье представлены варианты маркировки фармацевтической продукции и их характеристики. Затронуты проблемы информационного обеспечения системы прослеживания образцов лекарственных средств

Implementation of the drug samples tracing system

The article elaborates on a general overview of the tracing system and the possibilities of its implementation in the circulation of medicines. Moreover, it presents several variants of pharmaceutical production marking and the characteristics of those. The article touches upon the challenges of drug samples tracing system information support

Implementation of automated information systems into the work of the certification body of the federal state budgetary institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

The article describes the system of electronic document management related to the certification of medicinal immunobiological products (MIBP) in the Scientific Centre for Expert Evaluation of Medicinal Products», as well as historical aspects of its development. It also provides a brief description of CALS - the resources introduced into the expert institution’s activities, which are necessary for maintaining the life cycle of medicinal products. It specifies the main tasks that could be solved with the help of the IS «Document flow related to certification of MIBPs». The article enumerates the main development stages of the information system and its functional capabilities. It contains a review of certain modules of the IS «Document flow related to certification of MIBPs», implemented to meet modern standards of information security. It also summarizes the findings of the development of the IS «Document flow related to certification of MIBPs». The prospects of using the IS «Document flow related to certification of MIBPs» in the expert and scientific activities of the institution are also provided

Our first experience of prepectoral reconstruction of the mammary gland using a mesh polypropylene implant

Purpose of the study. To study the results of prepectoral reconstruction of the mammary gland after subcutaneous mastectomy for cancer with additional covering of the implant with a polypropylene mesh implant. (IPPBR)Materials and methods. Case-series of 6 patients with luminal breast cancer T1–2N0M0 aged from 34 to 47 years. IPPBR was performed after subcutaneous mastectomy (nipple sparing in 2 cases). The anterior surface of implants (Polytech, Germany) was covered with Ethicon/Johnson& Johnson (USA) simple polypropylene mesh. The mesh was fixed with interrupted absorbable sutures to the big pectoral muscle.Results. There was one successfully treated minor complication: limited skin incision necrosis. No other complications or tumor recurrences were registrated during observation period. The aesthetic results (mainly shape and volume breasts symmetry, nipples symmetry after nipple- sparing operation) were estimated as good both by surgeon and all patients. Periprosthetic connective tissue growth was minimal (grade I due to Baker’s scale) in all cases.Conclusion. The first results of the use of a simple mesh polypropylene implant in cases of breast cancer after subcutaneous mastectomy for cancer for the prevention of implant migration are encouraging. The degree of development of periprosthetic scar contracture is minimal