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S19 : Roundtable Discussion: Toward Implementation of a Single IRB
Session Chair(s)
Kiyomi Hirayama, PhD
Senior Director, Quality Management Unit Japan Development, MSD K.K., Japan
Speaker(s)
Tomoko Kataoka
Pharmaceutical Safety Bureau, Pharmaceutical Evaluation Division, Ministry of Health, Labour and Welfare (MHLW), Japan
Sakiko Ichijo
Chief, J-GCP based Clinical Trial Management Group, Academic Clinical Research C, Osaka University Hospital, Japan
Shin Nishikawa
TF2-5, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Yasuhiro Araki, PhD
Director, Office of Clinical Trial Promotion, Health Policy Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan
Akihiro Inano, PhD
Professor, Clinical Trial Center, Fukushima Medical University, Japan