CENTERS OF EXCELLENCE (CoEs)

Centers of Excellence	Priority Work Areas	Point of Contact
Peking University (PKU), China	Multi-Regional Clinical Trials & Good Clinical Practice Inspection [CoE] Pharmacovigilance [CoE]	CoE Director: Prof Yangfeng Wu Contact: [email protected]
Sichuan University (SCU), China	Medical Devices [CoE]	CoE Director: Prof Anyu Lee Contact: [email protected]
Kobe University, Japan	Biotherapeutic Products [CoE]	CoE Director: Prof Kazuhisa Uchida
Pharmaceutical and Medical Devices Agency (PMDA), Japan	Medical Devices [CoE] Multi-Regional Clinical Trials & Good Clinical Practice Inspection (with National Cancer Center (NCC), Japan) [CoE] Pharmacovigilance [CoE]	CoE Director: Mr Shinobu Uzu Contact: [email protected]
Korea Institute of Drug Safety and Risk Management (KIDS), Korea	Pharmacovigilance [CoE]	CoE Director: Ms E Na Song Contact: [email protected]
Korea National Enterprise for Clinical Trials (KoNECT), Korea	Multi-Regional Clinical Trials & Good Clinical Practice Inspection [CoE]	CoE Director: Dr In-seok Park Contact: KoNECT Global Cooperation Team/Ms Suji Yoo ([email protected] and [email protected])
National Institute of Medical Device Safety Information (NIDS), Korea	Medical Devices [CoE]	CoE Director: Mr Taigwon Kim Contact: Ms Raehyun Lee ([email protected] or [email protected])
Soonchunhyang University (SCH), Korea	Medical Devices [CoE]	CoE Director: Prof You Kyoung Lee Contact: [email protected] or [email protected]
Taylor’s University, Malaysia	Global Supply Chain Integrity [CoE]	CoE Director: Emeritus Professor P.T. Thomas Contact: [email protected]
Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore	Advanced Therapy Products [CoE] Biotherapeutics Products [Pilot CoE] Medical Devices [Pilot CoE] Multi-Regional Clinical Trials & Good Clinical Practice Inspection [CoE]	CoE Director: A/Prof Silke Vogel Contact: [email protected]
Taiwan Food and Drug Administration (TFDA), Chinese Taipei	Medical Devices [CoE]	CoE Director: Dr Shou-Mei Wu Contact: Ms Cheng-Ning Wu ([email protected])
Taiwan Food and Drug Administration (TFDA), Chinese Taipei	Good Registration Management [CoE]	CoE Director: Dr Shou-Mei Wu Contact: Ms Shianging Pan ([email protected]) Mr Kuo-Teng Hung ([email protected]) Dr Hsien-Yi Lin ([email protected]) Ms Chia-Wei Ting ([email protected])
Food and Drug Administration, Thailand (Thai FDA)	Good Registration Management [CoE]	CoE Director: Dr Suchart Chongprasert Contact: [email protected]
Northeastern University (NEU), United States	Advanced Therapy Products [CoE] Biotherapeutic Products [CoE] Medical Devices [Pilot CoE]	CoE Director: A/Dean Jared Auclair Contact: [email protected] or [email protected]
The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States	Multi-Regional Clinical Trials & Good Clinical Practice Inspection [CoE]	CoE Director: Dr Barbara E. Bierer Contact: [email protected]
The University of Tennessee Health Science Center (UTHSC), United States	Global Supply Chain Integrity [CoE]	CoE Director: Dr Kennard Brown
University of Southern California (USC), United States	Medical Devices [CoE]	CoE Director: Prof Frances Richmond Contact: [email protected]
United States Pharmacopeia (USP), United States	Advanced Therapy Products [CoE] Global Supply Chain Integrity [CoE]	CoE Director: Dr Fouad Atouf Contact: [email protected] Contact (Advanced Therapy Products & Supply Chain): Mr Michael Schmitz Contact: [email protected] Interim Contact (Supply Chain): Ms Ruth Lee Contact: [email protected]