FEATURES OF THE FOREIGN STUDENTS TRAINING IN THE ELECTIVE DISCIPLINE "QUALITY SYSTEMS IN PHARMACY"

Abstract

The pharmaceutical industry is rapidly developing and implementing new innovative approaches and legal regulation of the drugs quality management system, which includes a set of process methods and resources that are necessary for quality management. Therefore, the mastery by students of the specialty 226 "Pharmacy, Industrial Pharmacy" of the elective discipline "Quality Systems in Pharmacy" is an important issue of their professional training which will help them to master the methodology of quality management, normative-legislative and organizational-economic aspects of quality control of medicinal products at pharmaceutical enterprises. The elective discipline "Quality Systems in Pharmacy" is closely connected to some other disciplines, such as “Pharmacy and Industrial Technology of Drugs”, and “Technology of Cosmetic Drugs”. Training takes place according to the credit-module system in accordance with the basic requirements of the Bologna Convention. The main tasks of the elective discipline "Quality Systems in Pharmacy" are: providing the students with general knowledge about the quality indicators of medicines depending on the stage of their life cycle by fulfilling the requirements of good pharmaceutical practices and developing documentation in accordance with their requirements; formation of practical skills related to the rules and requirements for the creation, manufacture, research, distribution, sale, and storage of medicines in accordance with the requirements of good pharmaceutical practices operating in the European Union; improvement of the level of general and scientific development of students, formation of their outlook and perspective as modern qualified specialists in the field of pharmacy. The aim of the research is to study the peculiarities of the training of foreign students of the specialty 226 "Pharmacy, Industrial Pharmacy" in the Ivano-Frankivsk National Medical University (IFNMU) in the elective discipline "Quality Systems in Pharmacy". The subject of study of the discipline "Quality Systems in Pharmacy" is the methodology of pharmaceutical development, the components of the quality assurance system of medicines, including the requirements of the Guidelines of good practices in pharmacy for each stage of the life cycle of a medicinal product. The discipline is usually chosen by the well formed specialists. Teaching the elective discipline "Quality Systems in Pharmacy" at the specialty 226 "Pharmacy, Industrial Pharmacy" of IFNMU is necessary for students to thoroughly master the quality management system of medicines, it contributes to the optimization of the educational process and the improvement of the new principle of problem-oriented education of students and its control. This discipline orients students to the importance of the following issues: ensuring the quality of medicines at all stages of their life cycle; regulatory activities in the field of quality control of medicines; implementation of medicines; optimization and monitoring of pharmaceutical quality systems processes. This discipline forms the important competencies, knowledge, skills, abilities, and aspirations of students for self-development, while their teacher also develops and improves in the professional field together with students. Taking into account the trend of the European development of the pharmaceutical industry, the quality management system of medicines also should be harmonized with European standards.