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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
Senior 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)
About a Background and a Summary of Optimal Clinical Use Guidelines
Eri Sugiyama, MS
Ministry of Health, Labour and Welfare (MHLW), Japan
Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Heal
Optimal Use Guidelines : from the Viewpoints of Pharmaceutical Industry
Hiroyuki Muta
Ono Pharmaceutical Co., Ltd., Japan
Senior Director, Regulatory Management
Optimal Use Guidelines: Impact on Medical Practice
Makoto Tahara, MD, PhD
National Cancer Center Hospital East, Japan
Head and Neck Medical Oncology
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive