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Student Session
Session Chair(s)
Misato Mimura
Student, Public Health Emidemiology
Meiji Pharmaceutical University, Japan
Takuya Kaneko
Student, Public Heath Epidemiology
Meiji Pharmaceutical University, Japan
Kanako Iwasaki
Student, Department of Organic and Bioorganic Chemistry
Showa University, School of Pharmacy, Japan
Yuri Sugiura
Student, Department of Organic and Bioorganic Chemistry
Showa University, School of Pharmacy, Japan
Welfare (MHLW) for manufacturing and marketing drugs. In this session, we are going to gain a better understanding of the drug development by thinking about examination for the approval of drugs. This session will consist of: 1. Lecture on the important points when thinking about examination for the approval of drugs. 2. Discussion about the approval of one virtual drug by assessing efficacy and safety of the drug. 3. Presentation about the process to the conclusion of approving the drug or not by each group. It will be a great opportunity for students to learn the drug development and enhance the communication skills. Since the subject of this discussion is sleep-inducing drugs, reading a guideline (written in Japanese) in the URL (or QR) below is recommended. https://www.pmda.go.jp/files/000208186.pdf
Speaker(s)
The Basic Concept for Approval Review
Katsuhiko Ichimaru
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of New Drug IV
Understanding the Drug Development through Thinking of Approval Review
Misa Mori
IQVIA Servicies Japan K.K., Japan
Integrated Engagement Services Division
Ryosuke Araki
Chugai Pharmaceutical Co., Ltd., Japan