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 Moonjung Kim

Contact: [email protected]

Korea National Enterprise for Clinical Trials (KoNECT), Korea

Multi-Regional Clinical Trials & Good Clinical Practice Inspection [CoE]

CoE Director: Dr ByoungJun Bae

Contact: Ms Natalie Lee ([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])

 

TFDA with Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, Chinese Taipei

Good Registration Management [CoE]

CoE Director: Dr Shou-Mei Wu 

Contact:

Ms Chyn-Liang Huang ([email protected])

Ms Chia-Ping Liu ([email protected])

Ms Yi-Ju Lin ([email protected])

Dr Hsien-Yi Lin ([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]