Numbering Code	U-PHA00 3C315 LJ86	Year/Term	2022 ・ First semester
Number of Credits	2	Course Type	Lecture
Target Year	4th year students or above	Target Student
Language	Japanese	Day/Period	Tue.2
Instructor name	HIGUCHI YURIKO (Graduate School of Pharmaceutical Sciences Associate Professor) YAMAMOTO IZUMI (Part-time Lecturer)
Outline and Purpose of the Course	Those engaged in the manufacture, sale, and use of pharmaceutical products are required to properly understand and follow the relevant laws and systems and the pharmaceutical economy in order to provide safe, secure, and high-quality medical care to the public. In this course, in addition to the background, content, and operation of laws related to pharmaceutical work, students will learn about the role of the pharmaceutical-affairs system and administration in order to acquire basic knowledge and a practical understanding of relevant laws. In addition, the Japanese Pharmacopoeia is a standard for medically important drugs established by the Ministry of Health, Labor, and Welfare, pursuant to the provisions of the Pharmaceuticals and Medical Devices Act. These lectures will explain the history of the Japanese Pharmacopoeia, general rules that apply to all provisions, general methods of testing, and typical drugs listed in each pharmaceutical article to help students understand the significance and content of the Japanese Pharmacopoeia. The goal is for students to understand and acquire basic knowledge and skills that can be applied to actual drug evaluation.
Course Goals	1. Outline the laws, ethics, and responsibilities related to pharmaceutical work. 2. Explain the background, content, and operation of related laws and regulations. 3. Explain the healthcare system and the role that pharmacists should play within it. 4. Explain the outline of the Japanese Pharmacopoeia (history, social background, and internationalization). 5. Understand and make use of the structure of the Japanese Pharmacopoeia.
Schedule and Contents	(Japanese Pharmacopoeia) 1. Overview of the Japanese Pharmacopoeia: History, Social Background 2. Overview of the Japanese Pharmacopoeia: National Pharmacopoeia, International Harmonization 3. General rules 4. General rules for formulation 5. General test methods (heavy-metal test method, arsenic test method, qualitative reaction, etc.) 6. Outline of pharmaceutical-product articles (notation, content, comparison of international pharmacopoeias) 7. Items related to pharmaceutical-product articles 8. Mid-term exam (Pharmaceutical-affairs regulations) 9. Pharmaceuticals and Medical Devices Act (1) 10. Pharmaceuticals and Medical Devices Act (2) 11. Narcotics and Psychotropics Control Law, Opium Law/Cannabis Control Law, Stimulants Control Law 12. Poisonous and Deleterious Substances Control Law, Product Liability Law 13. Other related regulations 14. Medical system 15. Pharmaceutical economy
Evaluation Methods and Policy	Evaluation is based on the following: attendance and small tests 20%; mid-term exam 40%; and regular tests 40%. The mid-term exam and regular tests assess the students' ability to discuss regulatory laws and regulations and to outline (citing background and significance) the Japanese Pharmacopoeia, as well as basic knowledge of important items related to legal norms and systems.
Course Requirements	None
Study outside of Class (preparation and review)	Due to their very wide scope, lectures will progress fast and will only discuss the essential basics. Therefore, in addition to reviewing the lecture content, students are expected to learn independently about content not covered during the lectures.
Textbooks	Textbooks/References	山本いづみ 『実証　薬事関係法規　－薬事法規は生きている－』 (Kyouto Hirokawa Shoten)
References, etc.	『薬事衛生六法【学生版】』 (Yakuji Nippousha), 『第17改正日本薬局方解説書 学生版』 (Hirokawa Shoten)
Courses delivered by Instructors with Practical Work Experience	分類： ・実務に関連した内容の授業科目