Development strategy, plan, and regulatory affairs of drugs
| Numbering Code | P-PUB01 8H099 LB90 | Year/Term | 2022 ・ Second semester |
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| Number of Credits | 2 | Course Type | Lecture |
| Target Year | Professional degree students | Target Student | |
| Language | Japanese and English | Day/Period | Wed.3・4 |
| Instructor name | KAWAKAMI, KOJI (Graduate School of Medicine Professor) | ||
| Outline and Purpose of the Course |
Director and Instructors: (Director) Koji Kawakami (Professor, Pharmacoepidemiology), Shiro Tanaka (Program-specific Professor, Clinical Biostatistics), Madoka Sasaki (Osaka Seikei College), Yasuhiro Fujiwara (PMDA),Hiroi Kasai(Kyoto Univ. iACT), Haruko Yamamoto (PMDA),Takahiro Uchida (JOMDD), Ikuo Horii (Cambridge Univ.), Shigeyuki Wakitani (Mukogawa Women's Univ.),Yoko Uryuhara (Doshisya Univ.), Christian Elze (Catenion), Yoshie Onishi (CreativCeutical),Shinya Kimura (JMDC), Hisashi Urushihara (Keio Univ.), Izumi Sato(Professor，Nagasaki Univ. ),Toshiki Fukasawa(Assistant professor, Digital health) 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 and the regulatory review in terms of manufacturing and control, nonclinical studies, clinical protocol, the new drug applications, and post-marketing will be discussed. |
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| 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 and clinical trials. |
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| Schedule and Contents |
October 5 Drug Development strategy and translational research (Tanaka) October 12 Industry R&D and regulatory reviewer training: protocol review of clinical trial (Fujiwara) October 19 Industry R&D and regulatory reviewer training: CMC (Kawakami) October 26 Industry R&D and regulatory reviewer training: nonclinical studies (Sasaki) November 2 Project management of clinical trial (Kasai) November 9 Industry R&D and regulatory reviewer training: medical devices (1) (Yamamoto) November 16 The Changing Dynamics of Bio-pharmaceutical Innovation (Elze) November 30 Data review and personalized medicine in drug development (Horii) December 7 Industry R&D and regulatory reviewer training: regenerative medicine (Wakitani) December 14 Life cycle management of drug (Uryuhara) December 21 Drug epidemiology methodology training (Sato&Fukasawa) December 28 Pharmacoeconomics and value-based drug pricing (Onishi) January 4 Industry R&D and regulatory reviewer training: Post-marketing surveillance (Urushihara) January 11 Industry R&D and regulatory reviewer training: medical devices (2) (Uchida) January 18 Evaluation of medical database / health evaluation (Kimura) |
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| Evaluation Methods and Policy | Participation (50%) and report (50%) | ||
| Course Requirements | You must take this course along with the course H109 “Drug policy and regulations” and H079 “Drug development, evaluation and regulatory sciences” of Wednesday 2nd of the second semester for you to acquire fundamental understanding of the field. | ||
| 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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