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[V1-S5] Regulations for Conditional Accelerated Approval System and Early Access to Drug Products
Session Chair(s)
Toshio Fujimoto, MD, MBA
Vice President, Medicines Development Unit Japan, Eli Lilly Japan K.K., Japan
Recently, various regulations have been developed to make realize early access to drug products. In addition to the conventional Orphan Designation, Priority Review and Advanced Medical Care, plans for SAKIGAKE Designation, Conditional Accelerated Approval System, Expanded Access Trial and Patient-requested Treatment System have been established. This session will clarify the outline of Conditional Accelerated Approval System and compartmentalization with other regulations, discuss in depth for Expanded Access Trial and Patient-requested Treatment System including actions to be taken by pharmaceutical industry and in medical practice.
Speaker(s)
Yasuhiro Araki, PHD
Director, Office of Clinical Trial Promotion, Health Policy Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan
Conditional Early Approval System and Other Comparable Approval System in Japan
Kae Nakashima, DVM, PHD, MS
, Pfizer Japan Inc., Japan
Conditional Early Approval System and Expanded Access Trials - Expectations and Challenges from Industry Perspective -
Taro Shibata, MSC
Chief, Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Japan
Can We, Academic Researchers, Contribute for an Expediting Access Scheme in Japan?
Yasuhiro Fujiwara, MD, PHD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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