FORMAL CENTERS OF EXCELLENCE (CoEs)
Centers of Excellence | Priority Work Areas |
Peking University (PKU), China | Multi-Regional Clinical Trials & Good Clinical Practice Inspection Pharmacovigilance |
Sichuan University (SCU), China | Medical Devices |
Pharmaceutical and Medical Devices Agency (PMDA), Japan | Medical Devices Multi-Regional Clinical Trials & Good Clinical Practice Inspection (with National Cancer Center (NCC), Japan) Pharmacovigilance |
Korea Institute of Drug Safety and Risk Management (KIDS), Korea | Pharmacovigilance |
Korea National Enterprise for Clinical Trials (KoNECT), Korea | Multi-Regional Clinical Trials & Good Clinical Practice Inspection |
National Institute of Medical Device Safety Information (NIDS), Korea | Medical Devices |
Soonchunhyang University (SCH), Korea | Medical Devices |
Taylor's University, Malaysia | Global Supply Chain Integrity |
Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore | Advanced Therapy Products Multi-Regional Clinical Trials & Good Clinical Practice Inspection |
Taiwan Food and Drug Administration (TFDA), Chinese Taipei | Medical Devices |
TFDA with Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, Chinese Taipei | Good Registration Management |
Food and Drug Administration, Thailand (Thai FDA) | Good Registration Management |
Northeastern University (NEU), United States | Advanced Therapy Products Biotherapeutic Products |
The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States | Multi-Regional Clinical Trials & Good Clinical Practice Inspection |
The University of Tennessee Health Science Center (UTHSC), United States | Global Supply Chain Integrity |
University of Southern California (USC), United States | Medical Devices |
United States Pharmacopeia (USP), United States | Advanced Therapy Products Global Supply Chain Integrity |