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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)
Conditional Early Approval System and Other Comparable Approval System in Japan
Yasuhiro Araki
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director of Office of Vaccine and Blood Products
Conditional Early Approval System and Expanded Access Trials - Expectations and Challenges from Industry Perspective -
Kae Nakashima, DVM, PhD, MS
Pfizer Japan Inc., Japan
Can We, Academic Researchers, Contribute for an Expediting Access Scheme in Japan?
Taro Shibata, MSc
Center for Research Administration and Support, National Cancer Center, Japan
Chief, Biostatistics Division
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive