About APEC CoE
The APEC Regulatory Harmonization Steering Committee (RHSC) has established linkages with other harmonization/convergence initiatives, training institutions and key players in order to avoid duplication of effort, promote complementary action and make maximum use of resources. As a part of regulatory harmonization activities, the RHSC has initiated the establishment of Center of Excellence (CoE).
The CoE training is to benefit all parties that are engaged in the healthcare field by continuously providing quality training, and the following is the areas of pilot/formal training for APEC CoE:
- Multi-Regional Clinical Trials (MRCT) - Good Clinical Practices (GCP) Inspection
- Medical Product Quality and Supply Chain Integrity
- Biotherapeutics
- Pharmacovigilance (PV)
- Medical Device
- Advanced Therapies
- Good Registration Management (GRM)
CoE Institution
Formal CoE Institutions
PWAs(Roadmap) | PWA champion | Centers of Excellence(CoE) Institution | Region |
---|---|---|---|
Biotherapeutics Products | US Food & Drug Administration (The United States) Biotechnology Innovation Organization(BIO) |
Northeastern University (NEU) | The United States |
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school |
Singapore | ||
Kobe University | Japan | ||
Pharmacovigilance | Ministy of Food and Drug Safety (Korea) | Korea Institute of Drug Safety and Risk Management (KIDS) | Republic of Korea |
Pharmaceticals and Medical Devices Agency (PMDA) | Japan | ||
Pecking University (PKU) | China | ||
MRCT-GCP Inspection | Ministy of Health, Labour and Welfare (Japan) Pharmaceuticals and Medical Devices Agency (Japan) US Food & Drug Administration (Thai FDA) |
Pecking University (PKU) | China |
Pharmaceticals and Medical Devices Agency (PMDA) | Japan | ||
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school |
Singapore | ||
The MRCT Center of Brigham and Women's Hospital and Harvard (MRCT Center) | The United States | ||
Korea National Enterprise for Clinical Trials (KoNECT) | Republic of Korea | ||
Good Registration Management (GRM) | Taiwan Food & Drug Administration(TRDA), Chinese Taipei Ministy of Health, Labour and Welfare (Japan) Pharmaceuticals and Medical Devices Agency (Japan) |
Thai Food and Drug Administration (Thai FDA) | Thailand |
Food and Drug Administration, Chinese Taipei (TFDA) Regulatory Affairs Professionals Society (RAPS) Taiwan |
Chinese Taipei | ||
Global Supply Chain Integrity | US Food & Drug Administration (The United States) |
United States Pharmacopeial Convention (USPC) | The United States |
University of Tennessee Health Science Center (UTHSC) | |||
Taylor’s University | Malaysia | ||
Advanced Therapies Products | Health Sciences Authority(HAS), Singapore US Food & Drug Administration(The United States) Biotechnology Innovation Organization(BIO) |
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school |
Singapore |
Northeastern University (NEU) | The United States | ||
U.S. Pharmacopeia (USP) | |||
Advanced Therapies Products | Health Sciences Authority(HAS), Singapore US Food & Drug Administration(The United States) Biotechnology Innovation Organization(BIO) |
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school |
Singapore |
Northeastern University (NEU) | The United States | ||
U.S. Pharmacopeia (USP) | |||
Medical Device | Ministy of Health, Labour and Welfare (Japan) Pharmaceuticals and Medical Devices Agency (Japan) Ministy of Food and Drug Safety (Korea) US Food & Drug Administration (The United States) Japan Medical Imaging and Radiological Systems Industries Association(JIRA, Japan) Advanced Medical Technology Association(AdvaMed, United States) |
National Institute of Medical Device Safety Information (NIDS) | Republic of Korea |
Soonchunhyang University (SCH) | |||
Pharmaceticals and Medical Devices Agency (PMDA) | Japan | ||
Northeastern University(NEU) | The United States | ||
University of Southern California (USC) | |||
Taiwan Food & Drug Administration(TRDA) | Chinese Taipei | ||
Sichuan University (SCU) | China | ||
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school |
Singapore |
Pilot CoE Institutions
PWAs(Roadmap) | PWA champion | Centers of Excellence(CoE) Institution | Region |
---|---|---|---|
Biotherapeutics Products | US Food & Drug Administration (The United States) Biotechnology Innovation Organization(BIO) |
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school | Singapore |
Medical Device | Ministy of Health, Labour and Welfare (Japan) Pharmaceuticals and Medical Devices Agency (Japan) Ministy of Food and Drug Safety (Korea) US Food & Drug Administration (The United States) Japan Medical Imaging and Radiological Systems Industries Association(JIRA, Japan) Advanced Medical Technology Association(AdvaMed, United States) |
Northeastern University(NEU) | The United States |
Centre of Regulatory Excellence(CoRE) Duke-NUS Medical school |
Singapore |