Ubohov S. Methodological and applied foundations of the integrative model of quality assurance of medicines at the stages of realization and medical application

The thesis is devoted to scientific substantiation and development of methodological, organizational-methodical and applied foundations of formation and effective functioning of the integrative model of quality assurance of medicines at the stages of wholesale, retail realization and medical application, based on requirements of GxP and ethical codes, recommendations of ICH and international standards management systems of quality, ecology, hygiene and safety and social responsibility. The scientific-practical approaches for formation, implementation, documentation, evaluation and improvement of the pharmaceutical integrated quality systems in pharmaceutical institutions and hospitals have been substantiated. The methodological and organizational-applied approaches for implementation, support and improvement of the quality risk management process for medicines in pharmaceutical institutions and hospitals have been developed.