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 | Institution | Region |
|---|---|---|---|
| Biotherapeutics | The United States(Temporary) | Northeastern University (NEU) | The United States |
| Kobe University | Japan | ||
| Pharmacovigilance | Republic of Korea | Korea Institute of Drug Safety and Risk Management (KIDS) | Republic of Korea |
| PMDA Asia Training Center(PMDA-ATC) | Japan | ||
| Pecking University (PKU) | People’s Republic of China | ||
| MRCT-GCP Inspection | Japan / Thailand | Korea National Enterprise for Clinical Trials (KoNECT) | Republic of Korea |
| Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) | Singapore | ||
| PMDA Asia Training Center (PMDA-ATC) | Japan | ||
| Peking University (PKU) | People’s Republic of China | ||
| Harvard Brigham Women's Hospital MRCT Center | The United States | ||
| Good Registration Management (GRM) | Chinese Taipei / Japan | Food and Drug Administration, Chinese Taipei (TFDA) & Regulatory Affairs Professionals Society (RAPS) Taiwan | Chinese Taipei |
| Thai Food and Drug Administration (Thai FDA) | Thailand | ||
| Global Supply Chain Integrity | The United States | University of Tennessee Health Science Center (UTHSC) | The United States |
| United States Pharmacopeial Convention (USPC) | The United States | ||
| Taylor’s University | Malaysia | ||
| Advanced Therapies | Singapore | Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) | Singapore |
| Northeastern University (NEU) | The United States | ||
| Medical Device | Republic of Korea / Japan / The United States | National Institute of Medical Device Safety Information (NIDS) | Republic of Korea |
| Soonchunhyang University (SCH) | Republic of Korea | ||
| University of Southern California (USC) | The United States | ||
| PMDA Asia Training Center (PMDA-ATC) | Japan | ||
| Food and Drug Administration, Chinese Taipei (TFDA) | Chinese Taipei | ||
| Sichuan University (SCU) | People’s Republic of China | ||
| Please note that the name of economies were taken from the official website of APEC. | |||
Pilot CoE Institutions
| PWAs (Roadmap) | PWA Champion | Institution | Region |
|---|---|---|---|
| Biotherapeutics | The United States (Temporary) | Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) | Singapore |
| Advanced Therapies | Singapore | United States Pharmacopeial Convention (USPC) | The United States |
| Medical Device | Republic of Korea / Japan / The United States | Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) | Singapore |
| Ministry of Health, Malaysia | Malaysia | ||
| Please note that the name of economies were taken from the official website of APEC. | |||