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CoE Activities

CoE Institution

Formal CoE Institutions
PWAs (Roadmap) PWA Champion Institution Region
Biotherapeutics United States
(Temporary)
Northeastern University (NEU) United States
Kobe University Japan
Pharmacovigilance Korea Korea Institute of Drug Safety
and Risk Management (KIDS)
Korea
PMDA Asia Training Center
(PMDA-ATC)
Japan
Pecking University (PKU) China
MRCT-GCP Inspection Japan / Thailand Korea National Enterprise for
Clinical Trials (KoNECT)
Korea
Duke-NUS Centre of Regulatory
Excellence (Duke-NUS CoRE)
Singapore
PMDA Asia Training Center
(PMDA-ATC)
Japan
Peking University (PKU) China
Harvard Brigham Women's Hospital MRCT Center 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 United States University of Tennessee Health Science Center (UTHSC) United States
United States Pharmacopeial Convention (USPC) United States
Taylor’s University Malaysia
Advanced Therapies Singapore Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) Singapore
Northeastern University (NEU) United States
Medical Device Korea / Japan / United States National Institute of Medical Device Safety Information (NIDS) Korea
Soonchunhyang University (SCH) Korea
University of Southern California (USC) United States
PMDA Asia Training Center (PMDA-ATC) Japan
Food and Drug Administration, Chinese Taipei (TFDA) Chinese Taipei
Sichuan University (SCU) China
Pilot CoE Institutions
PWAs (Roadmap) PWA Champion Institution Region
Biotherapeutics United States (Temporary) Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) Singapore
Advanced Therapies Singapore United States Pharmacopeial Convention (USPC) United States
Medical Device Korea / Japan / United States Duke-NUS Centre of Regulatory Excellence (Duke-NUS CoRE) Singapore
Ministry of Health, Malaysia Malysia