APEC CoE

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:

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