Sponsor
Outside Japan
IQVIA ICCC
Inside Japan
SITES
SITES
IMPORT
IMPORT
PMDA
PMDA
• Contracting
• IRB documents
• Safety reporting
• IP & Lab kit delivery
IRB: Institutional Review Board
IP: Investigational Product
• Management of importation
• Compliance with GMP & GCP
• Storage
• Distribution
GMP: Good Manufacturing Practice
GCP: Good Clinical Practice
• CTN preparation
• CTN submission
• Follow-up meetings
• Safety reporting
PMDA: Pharmaceuticals and
Medical Devices Agency
