CENTERS OF EXCELLENCE (CoEs)
Centers of Excellence | Priority Work Areas | Point of Contact |
Multi-Regional Clinical Trials & Good Clinical Practice Inspection [CoE] Pharmacovigilance [CoE] | CoE Director: Prof Yangfeng Wu Contact: wuyf@bjmu.edu.cn | |
Sichuan University (SCU), China | Medical Devices [CoE] | CoE Director: Prof Anyu Lee Contact: javola@qq.com |
Kobe University, Japan | Biotherapeutic Products [CoE] | CoE Director: Prof Kazuhisa Uchida |
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: PMDA-ATC@pmda.go.jp | |
Korea Institute of Drug Safety and Risk Management (KIDS), Korea | Pharmacovigilance [CoE] | CoE Director: Ms E Na Song Contact: kids_coe@drugsafe.or.kr |
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 (global@konect.or.kr and suji.yoo@konect.or.kr) |
National Institute of Medical Device Safety Information (NIDS), Korea | Medical Devices [CoE] | CoE Director: Mr Taigwon Kim Contact: Ms Raehyun Lee (raehyun@nids.or.kr or raehyunlee.1026@gmail.com) |
Medical Devices [CoE] | CoE Director: Prof You Kyoung Lee Contact: schmd.coe@gmail.com or schmd.coe@schmc.ac.kr | |
Global Supply Chain Integrity [CoE] | CoE Director: Emeritus Professor P.T. Thomas Contact: Taylors.APECCOE@taylors.edu.my | |
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: CoRE@duke-nus.edu.sg |
Medical Devices [CoE] | CoE Director: Dr Shou-Mei Wu Contact: Ms Cheng-Ning Wu (emilywu@fda.gov.tw) | |
TFDA with Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, Chinese Taipei | Good Registration Management [CoE] | CoE Director: Dr Shou-Mei Wu Contact: Ms Shirley Pan (pashirle@fda.gov.tw) Ms Chia-Ping Liu (meat0901@fda.gov.tw) Ms Yi-Ju Lin (maylin25@fda.gov.tw) Dr Hsien-Yi Lin (hsienyilin@fda.gov.tw) Ms Chia-Wei Ting (dora1015@fda.gov.tw) |
Good Registration Management [CoE] | CoE Director: Dr Suchart Chongprasert Contact: grmthailand@fda.moph.go.th | |
Advanced Therapy Products [CoE] Biotherapeutic Products [CoE] Medical Devices [Pilot CoE] | CoE Director: A/Dean Jared Auclair Contact: BATL@northeastern.edu or j.auclair@northeastern.edu | |
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: mrct@bwh.harvard.edu |
The University of Tennessee Health Science Center (UTHSC), United States | Global Supply Chain Integrity [CoE] | CoE Director: Dr Kennard Brown |
Medical Devices [CoE] | CoE Director: Prof Frances Richmond Contact: fjr@usc.edu | |
United States Pharmacopeia (USP), United States | Advanced Therapy Products [CoE] Global Supply Chain Integrity [CoE] | CoE Director: Dr Fouad Atouf Contact: fa@usp.org Contact (Advanced Therapy Products & Supply Chain): Mr Michael Schmitz Contact: Michael.Schmitz@USP.org Interim Contact (Supply Chain): Ms Ruth Lee Contact: ruth.lee@usp.org |