I7075001 Pharmaceutical Affairs Related Laws

Hiroshima University Syllabus

Japanese

Academic Year 2024Year School/Graduate School School of Pharmaceutical Sciences Program of Pharmaceutical Sciences

Lecture Code I7075001 Subject Classification Specialized Education

Subject Name 薬事関係法規

Subject Name
（Katakana）ヤクジカンケイホウキ

Subject Name in
English Pharmaceutical Affairs Related Laws

Instructor FUSE JUNICHI,OZAWA KOICHIRO

Instructor
(Katakana) フセ　ジュンイチ,オザワ　コウイチロウ

Campus Kasumi Semester/Term 4th-Year,  First Semester,  2Term

Days, Periods, and Classrooms (2T) Weds1-4：霞R304講義室

Lesson Style Lecture Lesson Style
(More Details) 　

Lecture and using blackboard and OHP projector

Credits 2.0 Class Hours/Week 　 Language of Instruction B : Japanese／English

Course Level 3 : Undergraduate High-Intermediate

Course Area（Area） 27 : Health Sciences

Course Area（Discipline） 03 : Pharmaceutical Sciences

Eligible Students Fourth-year undergraduates of Pharmaceutical sciences

Keywords SDG_03 SDG_12 SDG_17 pharmaceutical jurisprudence, japanese pharmaceutical affairs law, pharmacists law, Pharmaceuticals and Medical Devices Agency, medical-care insurance, control laws for toxic materials and deleterious substance, control laws for narcotic drugs, medical service law, public nursing care insurance law

Special Subject for Teacher Education 　 Special Subject 　

Class Status
within Educational
Program
(Applicable only to targeted subjects for undergraduate students)
Criterion referenced
Evaluation
(Applicable only to targeted subjects for undergraduate students) Pharmaceutical Sciences
（Knowledge and Understanding）
・The basic knowledge and understanding of basic structures, physical characters and reaction of medicine and other inorganic and organic compounds. ●quality ⑤
・Understanding concerning preservation of the eco system and life environment, causes of environmental pollutants, and their influences on humans ●credential⑦
・Knowledge and understanding about rational analyses of pharmacokinetics in order to to understand quantitatively madicinal effects or side effects●qualities ⑥
・The knowledge and understanding of communication with medical teams relating to medication. ● quality ③、④
（Abilities and Skills）
・To be able to handle major analysis methods written in the Japanese Pharmacopoeia credential⑤
・To be able to handle quality control based on major testing methodology related to pharmaceutical formulations stipulated in the Japanese Pharmacopoeia credential⑤
（Attitudes）
・Self-betterment of character formation as a medical professional : the appropriate action and attitude being aware of that a pharmacist is a professional relating to human life.  The knowledge and understanding to have communication not only with ailing people but with other medical staff in a medical team.  ●quality ①　②　③　④　⑨

Medicinal Sciences
（Knowledge and Understanding）
・The knowledge relating to mutual reaction between chemical compounds including medicine and a human body

Class Objectives
/Class Outline GIO: In order to become a pharmacist, to learn the basic knowledge about laws and restrictions related to pharmacist and medical care.
Summary of the class：To lecture the basic knowledge about laws and restrictions related to pharmacist and medical care.

Class Schedule lesson 1: Overview
lesson 2: Drug regulatory affairs laws (1)
lesson 3: Drug regulatory affairs laws (2)
lesson 4: Control laws for toxic materials and deleterious substance (1)
lesson 5: Control laws for toxic materials and deleterious substance (2)
lesson 6: Control laws for production of medical substances, Control laws for medical equipment
lesson 7: Control laws for a criminal and civil liability of the pharmacist
lesson 8: Relief system for sufferers from adverse drug reactions (1)
lesson 9: Relief system for sufferers from adverse drug reactions (2)
lesson 10: Pharmacists law (1)
lesson 11: Pharmacists law (2)
lesson 12: Control laws for narcotic drugs (1)
lesson 13: Control laws for narcotic drugs (2)
lesson 14: Medical service law (1)
lesson 15: Medical service law (2)

Text/Reference
Books,etc. Text: Laws and restrictions in Japan, Kyoto Hirokawa
Resume

PC or AV used in
Class,etc. 　

(More Details) OHP and power point

Learning techniques to be incorporated 　

Suggestions on
Preparation and
Review lesson 1: Please read “Overview”of the textbook and review the class.  You will take a small test in a next beginning.
lesson 2 and 3: Please read Chapter 1 of the textbook and review the class.  You will take a small test in a next beginning.
lesson 4 and 5: Please read Chapter 5 of the textbook and review the class.  You will take a small test in a next beginning.
lesson 6 and 7: Please read Chapter 1 and 4-6 of the textbook and review the class.  You will take a small test in a next beginning.
lesson 8 and 9: Please read Chapter 3 of the textbook and review the class.  You will take a small test in a next beginning.
lesson 10 and 11: Please read Chapter 2 of the textbook and review the class.  You will take a small test in a next beginning.
lesson 12 and 13: Please read Chapter 6 of the textbook and review the class.  You will take a small test in a next beginning.
lesson 14 an

Requirements

Grading Method The term examination 90 points, small tests 10 points; 100 points in total.

Practical Experience Experienced

Summary of Practical Experience and Class Contents based on it A teacher who has the experience which participated in pharmacist work lectures on basic knowledge about works at a hospital and a pharmacy.

Message

Other MODEL CORE CURRICULUM FOR PHARMACY EDUCATION：B-(1)-3, B-(1)-4, B-(1)-5, B-(2)-①-1, B-(2)-①-2, B-(2)-①-3, B-(2)-①-4, B-(2)-①-5, B-(2)-①-6, B-(2)-①-7, B-(2)-①-8, B-(2)-②-1, B-(2)-②-2, B-(2)-②-3, B-(2)-②-4, B-(2)-②-5, B-(2)-②-6, B-(2)-②-7, B-(2)-②-8, B-(2)-②-9, B-(2)-②-10, B-(2)-③-1, B-(2)-③-2, B-(2)-③-3, B-(3)-①-1, B-(3)-①-2, B-(3)-①-3, B-(3)-①-4, B-(3)-①-5, B-(3)-①-6, B-(3)-①-7, B-(3)-②-1, B-(3)-②-2, B-(3)-②-3, B-(3)-②-4, B-(4)-①-1, B-(4)-①-2, B-(4)-①-3, B-(4)-①-4, B-(4)-①-5, B-(4)-①-6, B-(4)-②-1, B-(4)-②-2, B-(4)-②-3, B-(4)-②-4, B-(4)-②-5

Please fill in the class improvement questionnaire which is carried out on all classes.
Instructors will reflect on your feedback and utilize the information for improving their teaching.

Academic Year	2024Year	School/Graduate School	School of Pharmaceutical Sciences Program of Pharmaceutical Sciences
Lecture Code	I7075001	Subject Classification	Specialized Education
Subject Name	薬事関係法規
Subject Name （Katakana）	ヤクジカンケイホウキ
Subject Name in English	Pharmaceutical Affairs Related Laws
Instructor	FUSE JUNICHI,OZAWA KOICHIRO
Instructor (Katakana)	フセ　ジュンイチ,オザワ　コウイチロウ
Campus	Kasumi	Semester/Term	4th-Year, First Semester, 2Term
Days, Periods, and Classrooms	(2T) Weds1-4：霞R304講義室
Lesson Style	Lecture	Lesson Style (More Details)
Lecture and using blackboard and OHP projector
Credits	2.0	Class Hours/Week		Language of Instruction	B : Japanese／English
Course Level	3 : Undergraduate High-Intermediate
Course Area（Area）	27 : Health Sciences
Course Area（Discipline）	03 : Pharmaceutical Sciences
Eligible Students	Fourth-year undergraduates of Pharmaceutical sciences
Keywords	SDG_03 SDG_12 SDG_17 pharmaceutical jurisprudence, japanese pharmaceutical affairs law, pharmacists law, Pharmaceuticals and Medical Devices Agency, medical-care insurance, control laws for toxic materials and deleterious substance, control laws for narcotic drugs, medical service law, public nursing care insurance law
Special Subject for Teacher Education		Special Subject
Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students)
Criterion referenced Evaluation (Applicable only to targeted subjects for undergraduate students)	Pharmaceutical Sciences （Knowledge and Understanding）・The basic knowledge and understanding of basic structures, physical characters and reaction of medicine and other inorganic and organic compounds. ●quality ⑤ ・Understanding concerning preservation of the eco system and life environment, causes of environmental pollutants, and their influences on humans ●credential⑦ ・Knowledge and understanding about rational analyses of pharmacokinetics in order to to understand quantitatively madicinal effects or side effects●qualities ⑥ ・The knowledge and understanding of communication with medical teams relating to medication. ● quality ③、④ （Abilities and Skills）・To be able to handle major analysis methods written in the Japanese Pharmacopoeia credential⑤ ・To be able to handle quality control based on major testing methodology related to pharmaceutical formulations stipulated in the Japanese Pharmacopoeia credential⑤ （Attitudes）・Self-betterment of character formation as a medical professional : the appropriate action and attitude being aware of that a pharmacist is a professional relating to human life. The knowledge and understanding to have communication not only with ailing people but with other medical staff in a medical team. ●quality ①　②　③　④　⑨ Medicinal Sciences （Knowledge and Understanding）・The knowledge relating to mutual reaction between chemical compounds including medicine and a human body
Class Objectives /Class Outline	GIO: In order to become a pharmacist, to learn the basic knowledge about laws and restrictions related to pharmacist and medical care. Summary of the class：To lecture the basic knowledge about laws and restrictions related to pharmacist and medical care.
Class Schedule	lesson 1: Overview lesson 2: Drug regulatory affairs laws (1) lesson 3: Drug regulatory affairs laws (2) lesson 4: Control laws for toxic materials and deleterious substance (1) lesson 5: Control laws for toxic materials and deleterious substance (2) lesson 6: Control laws for production of medical substances, Control laws for medical equipment lesson 7: Control laws for a criminal and civil liability of the pharmacist lesson 8: Relief system for sufferers from adverse drug reactions (1) lesson 9: Relief system for sufferers from adverse drug reactions (2) lesson 10: Pharmacists law (1) lesson 11: Pharmacists law (2) lesson 12: Control laws for narcotic drugs (1) lesson 13: Control laws for narcotic drugs (2) lesson 14: Medical service law (1) lesson 15: Medical service law (2)
Text/Reference Books,etc.	Text: Laws and restrictions in Japan, Kyoto Hirokawa Resume
PC or AV used in Class,etc.
(More Details)	OHP and power point
Learning techniques to be incorporated
Suggestions on Preparation and Review	lesson 1: Please read “Overview”of the textbook and review the class. You will take a small test in a next beginning. lesson 2 and 3: Please read Chapter 1 of the textbook and review the class. You will take a small test in a next beginning. lesson 4 and 5: Please read Chapter 5 of the textbook and review the class. You will take a small test in a next beginning. lesson 6 and 7: Please read Chapter 1 and 4-6 of the textbook and review the class. You will take a small test in a next beginning. lesson 8 and 9: Please read Chapter 3 of the textbook and review the class. You will take a small test in a next beginning. lesson 10 and 11: Please read Chapter 2 of the textbook and review the class. You will take a small test in a next beginning. lesson 12 and 13: Please read Chapter 6 of the textbook and review the class. You will take a small test in a next beginning. lesson 14 an
Requirements
Grading Method	The term examination 90 points, small tests 10 points; 100 points in total.
Practical Experience	Experienced
Summary of Practical Experience and Class Contents based on it	A teacher who has the experience which participated in pharmacist work lectures on basic knowledge about works at a hospital and a pharmacy.
Message
Other	MODEL CORE CURRICULUM FOR PHARMACY EDUCATION：B-(1)-3, B-(1)-4, B-(1)-5, B-(2)-①-1, B-(2)-①-2, B-(2)-①-3, B-(2)-①-4, B-(2)-①-5, B-(2)-①-6, B-(2)-①-7, B-(2)-①-8, B-(2)-②-1, B-(2)-②-2, B-(2)-②-3, B-(2)-②-4, B-(2)-②-5, B-(2)-②-6, B-(2)-②-7, B-(2)-②-8, B-(2)-②-9, B-(2)-②-10, B-(2)-③-1, B-(2)-③-2, B-(2)-③-3, B-(3)-①-1, B-(3)-①-2, B-(3)-①-3, B-(3)-①-4, B-(3)-①-5, B-(3)-①-6, B-(3)-①-7, B-(3)-②-1, B-(3)-②-2, B-(3)-②-3, B-(3)-②-4, B-(4)-①-1, B-(4)-①-2, B-(4)-①-3, B-(4)-①-4, B-(4)-①-5, B-(4)-①-6, B-(4)-②-1, B-(4)-②-2, B-(4)-②-3, B-(4)-②-4, B-(4)-②-5
Please fill in the class improvement questionnaire which is carried out on all classes. Instructors will reflect on your feedback and utilize the information for improving their teaching.

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