Safety Management Institution for Advanced Regenerative Medicine
In accordance with Article 19 of the Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products, the Korea National Institute of Health was designated as a "Safety Management Institution" in order to ensure the safety of advanced regenerative medicine.
Key roles
Advanced Regenerative Medicine Information system(ARMI)
An information system for collection and management of advanced regenerative medicine clinical studies data
Advanced Regenerative Medicine Information system
Regenerative
medical institutions
Management of clinical studies
Reporting on adverse event
Reporting on institutions’
current status
Checking of statistics by project
Cell processing
facilities
Reporting on cell
processing business
Safety management
institution
Management
of institution
Safety
monitoring
Management of
adverse event
Management of long-term
follow-up study
Operation of the advisory group for the safety management of advanced regenerative medicine
Review and advise on what is necessary for the safety management of advanced regenerative medicine