外国学生在 "药学质量体系 "选修科目中接受培训的特点

G.Yu. Starchenko, O. Struk, T.Z. Kostashchuk, I.A. Sas
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引用次数: 0

摘要

制药行业正在迅速发展并实施新的创新方法和药品质量管理体系的法律规定,其中包括一套质量管理所需的流程方法和资源。因此,226 "药剂学、工业药剂学 "专业的学生掌握选修学科 "药剂学质量体系 "是其专业培训的一个重要问题,这将有助于他们掌握质量管理的方法、制药企业药品质量控制的规范-法律和组织-经济方面。药剂学质量体系 "选修科目与 "药剂学和药品工业技术"、"药品化妆品技术 "等其他学科密切相关。根据《博洛尼亚公约》的基本要求,培训采用学分模块制。药剂学质量体系 "选修科目的主要任务是:根据药品生命周期的不同阶段,向学生传授有关药品质量指标的一般知识,满足良好制药规范的要求,并根据其要求编制文件;根据欧盟良好制药规范的要求,培养与药品的创造、制造、研究、分配、销售和储存的规则和要求有关的实践技能;提高学生的综合和科学发展水平,培养他们作为药剂学领域现代合格专家的视野和观点。研究的目的是研究伊万诺-弗兰科夫国立医科大学 226 "药学、工业药学 "专业的外国学生在选修科目 "药学质量体系 "方面的特殊性。药剂学质量体系 "学科的研究课题是药品开发方法、药品质量保证体系的组成部分,包括《药剂学良好实践指南》对药品生命周期各阶段的要求。该学科通常由基础扎实的专家选择。在国立莫斯科国立师范大学 226 "药学、工业药学 "专业开设 "药学质量体系 "选修课是学生全面掌握药品质量管理体系的必要条件,有助于优化教学过程,改进以问题为导向的学生教育及其控制的新原则。这门学科使学生认识到以下问题的重要性:确保药品在其生命周期各个阶段的质量;药品质量控制领域的监管活动;药品的实施;药品质量体系过程的优化和监控。这门学科为学生的自我发展培养了重要的能力、知识、技能、才干和抱负,而教师也与学生一起在专业领域不断发展和进步。考虑到欧洲制药业发展的趋势,药品质量管理体系也应与欧洲标准保持一致。
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FEATURES OF THE FOREIGN STUDENTS TRAINING IN THE ELECTIVE DISCIPLINE "QUALITY SYSTEMS IN PHARMACY"
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.
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