Bпровадження сучасних підходів в управління НДДКР у фармації

Abstract

У статті обґрунтовано необхідність застосування сучасних підходів в управлінні НДДКР у фармацевтичній галузі. Проаналізовано наявне нормативно-правове забезпечення сфери НДДКР у фармації. Обґрунтовано концептуальну модель управління НДДКР у фармації. Розроблено структуру та складові системи управління НДДКР у фармації.

В статье обоснована необходимость использования современных подходов в управлении НИОКР в фармацевтической отрасли. Проанализировано имеющееся нормативно-правовое обеспечение сферы НИОКР в фармации. Обоснована концептуальная модель управления НИОКР в фармации. Разработана структура и составляющие системы управления НИОКР в фармации.

Current state of art in pharmaceutical branch is characterized by increasing significance of science not only in drugs development, but also in their manufacturing and distribution. It had been proven by carried out research that R&D are present at each stage of pharmaceutical products lifecycle. Ukraine recently had joined the harmonization processes in area of quality management methodology. But despite that, while modern and effective R&D management system in pharmacy is absent, both increasing of scientific-technical level and competitive potential of national pharmaceutical companies are impossible. Despite the great amount of scientific publications on particular aspects of pharmaceutical R&D organization and management, R&D effectiveness and efficiency increase in this branch could be reached only by development and implementation of R&D management as a comprehensive whole. The analysis of current regulatory and legal support of R&D sphere in pharmacy had shown that most of R&D stages have appropriate legal background, but it does not facilitate comprehension of R&D as an integral process. Basing on study results of current regulatory, the R&D management concept model had been developed. According to the model, regulatory and legal background for R&D management system in pharmacy is integrated current normative documents, ICH Q8- Q10 guidelines and GMP requirements. This system should also consider the principles of knowledge management, management’s responsibility, quality risks management and continual improvement. Basing on study results of national pharmaceutical companies scientific activity, the structure and content of R&D management system had been justified. As far as goals and extent of R&D at different stages are different, there had been made an accent on application specifics of R&D management system. Suggested management system completely corresponds with current branch guidelines and enables effective and efficient management of R&D processes in pharmacy.