Drug Policy and Regulation

Numbering Code P-PUB01 8H109 LB90 Year/Term 2021 ・ The first half of second semester
Number of Credits 1 Course Type Lecture
Target Year Professional degree students Target Student
Language Japanese and English Day/Period Wed.2
Instructor name KAWAKAMI, KOJI (Graduate School of Medicine Professor)
Outline and Purpose of the Course Director and Instructors:
(Director) Koji Kawakami (Professor,Pharmacoepidemiology),
Yasuhiro Nishijima (Okayama Pref.), Keisuke Matsubayashi (Suita city)

The policy and regulatory systems in Japan, EU, and the US involving healthcare, safety, science, food safety,
and industry will be discussed.

Course Goals To understand the ideas of drug/medical device/food policy and regulations; medical industrialization and translational research policy.
Schedule and Contents Lecture schedule:

October 6 Drug policy and regulations (Kawakami)
October 13 Drug regulation in the United states (Kawakami)
October 20 Policy and development of medical devices (Kawakami)
October 27 Drug regulation in Japan (Undecided)
November 10 Food safety regulations (Nisijima)
November 17 Health insurance system and coverage of pharmaceuticals (Matsubayashi)
Evaluation Methods and Policy Participation (50%) and report (50%)
Course Requirements You must take this course along with the course H079 “Drug Development, Evaluation and Regulatory
Sciences” otherwise the entire grasp of the drug research, development, and regulations will not be achieved.
Study outside of Class (preparation and review) Preparation in advance and review after lecture
References, etc. Invitation to new drug development., Saeko Yasuo et al., ( Kyoritsu Press, 2006 )
Strom's Textbook of Pharmacoepidemiology, Koji Kawakami, Hisashi Urushihara, Shiro Tanaka et al. ed., (NANZANDO Co.,Ltd., 2019.)
Introduced during class
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