Drug Policy and Regulation
| Numbering Code | G-GAIS00 73031 LB90 | Year/Term | 2022 ・ Second semester |
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| Number of Credits | 1 | Course Type | Lecture |
| Target Year | From 1st to 3rd year 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), Hiroaki Mamiya (CiRA) 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. |
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| Course Goals | To understand idea of the drug/medical device/food policy and regulations; medical industrialization and translational research policy | ||
| Schedule and Contents |
October 5 Drug policy and regulations (Kawakami) October 12 Drug regulation in the United states (Kawakami) October 19 Policy and development of medical devices (Kawakami) October 26 Drug regulation in Japan (Mamiya) November 2 Food safety regulations (Nishijima) November 9 Health insurance system and coverage of pharmaceuticals (Matsubayashi) |
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| Evaluation Methods and Policy | Participation (50%) and report (50%) | ||
| Course Requirements | You must take this course along with the course 3012 “Drug Development, Evaluation and Regulatory Science” 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.) |
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