Abstract
The article presents the results of the analysis of alternative methods of studying theGood Pharmaceutical Practice complex, introduced at the Lviv Polytechnic National University.The optimal structure of the curriculum for student’s education by the specialty 226 “Pharmacy,Industrial Pharmacy” was determined to improve the system of training of specialists,who need understand the current pharmaceutical legislation of Ukraine and prospects for itsdevelopment.Structural-and-logical schemas based on the Guidelines of Good Pharmaceutical Practicesthat greatly facilitate students’ perception and assimilation of all the needed informationhave been elaborated.The development of such schemes by students with teacher assistance allows to improvethe perception of the material and strengthen skills for independently analyzing. While performingthe task, students to learn and understand certain aspects, such as the fact that the quality ofthe medicines is “incorporated” into the drug at the stage of pharmaceutical development, andthen confirmed during preclinical and clinical research. Further, the medicine receives a “permitto life”, when passing state registration. After that, the specified quality is reproduced for eachseries at the stage of full-scale pharmaceutical manufacturing, it is maintained unchanged at thestages of storage and distribution and, finally, it is delivered to patients in pharmacies. The study of the possibility of mastering the discipline “Good Practices in Pharmaceutics”by students of specialty 226 “Pharmacy, Industrial Pharmacy” during the practice at theexisting pharmaceutical enterprises can be considered perspective.
Highlights
Adaptation of Ukrainian legislation to the acquis communautaire of the European Union is one of the main components of the European integration policy of Ukraine
The research aimed involving student audience to analyze the alternative methods of studying the complex of Good Pharmaceutical Practices, introduced for educational process at the Lviv Polytechnic National University and to determine the optimal structure of curriculum for the student’s education by the specialty 226 “Pharmacy, Industrial Pharmacy” to improve the system of training of specialists, who need understanding the current pharmaceutical legislation of Ukraine and the prospects for its development
The main objective of this discipline is setting in students the basic concepts of Good Pharmaceutical Practices, focusing on the main requirements of Good Practices and features of each step of the medicine life cycle: pharmaceutical development, preclinical research, clinical trials, registration and amendments to the registration documents, mass production, storage, wholesale and retail sale of medicines (Koster, Schalekamp, Meijerman, 2017; Pearson, Hubball, 2012; Meijerman, Nab, Koster, 2016)
Summary
Summary The article presents the results of the analysis of alternative methods of studying the Good Pharmaceutical Practice complex, introduced at the Lviv Polytechnic National University. The optimal structure of the curriculum for student’s education by the specialty 226 “Pharmacy, Industrial Pharmacy” was determined to improve the system of training of specialists, who need understand the current pharmaceutical legislation of Ukraine and prospects for its development. Structural-and-logical schemas based on the Guidelines of Good Pharmaceutical Practices that greatly facilitate students’ perception and assimilation of all the needed information have been elaborated. The development of such schemes by students with teacher assistance allows to improve the perception of the material and strengthen skills for independently analyzing.
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