Course title<English>Affiliated

医薬品・医療機器の開発計画、薬事と審査 department,Graduate School of Medicine
Development strategy, plan, and regulatory affairs of drugs and medical devices Job title,Name Professor,KAWAKAMI KOJI

Grade alloted Professional degree students Number of credits 2
Day/period Wed.3,4Class style

LectureCourse offeredyear/period

2016/Second semester

Language Japanese and English[Outline and Purpose of the Course]
Director and Instructors:(Director) Koji Kawakami (Professor, Pharmacoepidemiology) Shiro Tanaka (Associate Professor,Pharmacoepidemiology.), Junko Komura (PMDA), Yasuhiro Fujiwara (National Cancer Center), Miyuki
Niimi (Saku General Hospital), Christian Elze (Catenion), Haruko Yamamoto (National Cerebral andCardiovascular Center), Hiromu Kutsumi (Shiga Univ. Of Medical Science), Ikuo Horii (Cambridge Univ.),
Yoko Uryuhara (Doshisya Univ.), Shigeyuki Wakitani (Mukogawa Women's Univ.), Hisashi Urushihara(Keio Univ.), Shinya Kimura (Japan Medical Data Center), Yoshie Onishi (CreativCeutical)
The development strategy, protocol design, project management, safety/efficacy assessment, and economic
evaluation of drugs and medical devices will be lectured. The development of drug and medical device andthe regulatory review in terms of manufacturing and control, nonclinical studies, clinical protocol, the new
drug applications, and post-marketing will be discussed.
[Course Goals]
・The idea of drug/medical device development and regulatory review will be understood.
・To understand the strategy, protocol development, and project management of drug development andclinical trials.
[Course Schedule and Contents]
Lectures and discussions※Lecture schedule
October 5 Drug Development strategy and translational research (Tanaka)
October 12 Industry R&D and regulatory reviewer training: nonclinical studies (Komura)
October 19 Industry R&D and regulatory reviewer training: CMC (Kawakami)
October 26 Industry R&D and regulatory reviewer training: protocol review of clinical trial (Fujiwara)
November 2 Project management of clinical trial (Niimi)
November 9 Global Development Strategy of New Drugs (Elze)
November 16 Industry R&D and regulatory reviewer training: medical devices (1) (Yamamoto)
November 30 Industry R&D and regulatory reviewer training: medical devices (2) (Kutsumi)
December 7 Data review and personalized medicine in drug development (Horii)
December 14 Life cycle management of drug (Uryuhara)
December 21 Industry R&D and regulatory reviewer training: regenerative medicine (Wakitani)
January 4 Industry R&D and regulatory reviewer training: postmarket (Urushihara)
January 11 Application of medical database in evaluation of health care (Kimura)January 18 Health economy and outcomes research: Practice (Onishi)
January 25 Sight visiting of Kobe medical cluster (Tanaka)Continue to 医薬品・医療機器の開発計画、薬事と審査(2)↓↓↓− 287 −医薬品・医療機器の開発計画、薬事と審査(2)[Class requirement]
You must take this course along with the course H074 Drug policy and regulations and H079 Drugdevelopment, evaluation and regulatory sciences of Wednesday 2nd of the second semester for you toacquire fundamental understanding of the field.
[Method, Point of view, and Attainment levels of Evaluation]
Participation (50%) and report (50%)[Textbook]
Suggested reading:
Saeko Yasuo et al. Invitation to new drug development. Kyoritsu Press, 2006 (Japanese).
Koji Kawakami (ed.) The Beginner s guidance to the clinical research and development. Medical Do, 2010
(Japanese).

[Reference books, etc.]（Reference books）
Introduced during class[Regarding studies out of class (preparation and review)]
Preparation in advance and review after lecture（Others (office hour, etc.) ）Koji Kawakami （3F, Bldg G）appointment required by email.
e-mail: kawakami.koji.4e@kyoto-u.ac.jp*Please visit KULASIS to find out about office hours.

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