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[V1-S6] Optimal Use Guidelines (Future Direction of the System, Discussion of the NDA Review Process, and Status of Actual Medical Practice)
Session Chair(s)
Yuji Kashitani
Executive Director, Regulatory Policy & Innovation, Takeda , Japan
Discussion on the direction toward the official introduction of ‘Optimal Use Guidelines’ being in trial operation from FY2016. This session will discuss including the future issues, the target products planned for the Guidelines, impact on creating NDA dossiers or review for NDA approval when introduced the Guidelines, or any change or impact to the actual medical practice when Guidelines are introduced.
Speaker(s)
Eri Sugiyama, MS
Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Heal, Ministry of Health, Labour and Welfare (MHLW), Japan
About a Background and a Summary of Optimal Clinical Use Guidelines
Hiroyuki Muta
Senior Director, Regulatory Management, Ono Pharmaceutical Co., Ltd., Japan
Optimal Use Guidelines : from the Viewpoints of Pharmaceutical Industry
Makoto Tahara, MD, PHD
Head and Neck Medical Oncology, National Cancer Center Hospital East, Japan
Optimal Use Guidelines: Impact on Medical Practice
Yasuhiro Fujiwara, MD, PHD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan