Drug Development, Evaluation and Regulatory Sciences

Numbering Code P-PUB01 8H079 LB90 Year/Term 2021 ・ Intensive, Second semester
Number of Credits 1 Course Type Lecture
Target Year Professional degree students Target Student
Language Japanese and English Day/Period Intensive
Instructor name KAWAKAMI, KOJI (Graduate School of Medicine Professor)
Outline and Purpose of the Course Director and Instructors:
(Director) Koji Kawakami (Professor,Pharmacoepidemiology)
Hiromitsu Shirasawa (MSD, Japan),
Ikuo Horii (Cambridge Univ.), Izumi Sato (Professor,Nagasaki Univ.), Christian Elze (Catenion),
Yoshie Onishi (Creativ Ceutical), Toyoda Masahiro (MOF), Hisashi Urushihara (Keio Univ.), Sachiko Tanaka(Program specific professor, Digital health)


The efficacy and safety of the drug, biologics, and medical devices are evaluated through the drug
development process involving preclinical and clinical studies, manufacturing, and post-marketing surveillance. Also, cost/benefit consideration through the comparative effective research is necessary.
Fundamental considerations of these issues along with research examples will be discussed.
Course Goals To understand idea of the development, evaluation, cost/benefit of medicinal products.
Schedule and Contents November 24 Healthcare Systems - Challenges and Reform(Elze)
December 1 Drug development and toxicity/safety (Horii)
December 8 Regulatory affairs in the globalwide pharmaceutical company (Shirasawa)
December 15 Medical real world data and Medicine evaluation(Kawakami)
December 22 An introduction to Pharmacoepidemiology (Sato)
January 5 Pharmacoeconomics and value-based drug pricing (Onishi)
January 12 Finance of Japan and healthcare (Toyoda)
January 19 Postmarketing surveillance (Urushihara)
January 26 Digital health and epidemiology(Tanaka)
Evaluation Methods and Policy Participation (50%) and report (50%)
Course Requirements You must take this course along with the course H109 “Drug policy and regulation” 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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