The goals of the Roadmap for MRCTs and GCP Inspection PWA are to facilitate implementation of MRCTs and acceptance of MRCT results for drug review by regulatory authorities in APEC region and to promote best practice of GCP inspection. To reach the goals, CoEs are providing training programs so as to disseminate relevant internationally harmonized guidelines such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A, E2F, E5(R1), E6(R1, R2), E8, E9, E10 and E17.
CO-CHAMPIONS
- Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Food and Drug Administration, Thailand (Thai FDA)
The PWA Co-Champions’ contacts can be found here.
CENTERS OF EXCELLENCE
- Peking University (PKU), China
- Pharmaceuticals and Medical Devices Agency (PMDA) with National Cancer Center (NCC), Japan
- Korea National Enterprise for Clinical Trials (KoNECT), Korea
- Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
- The MRCT Center of Brigham and Women's Hospital and Harvard (MRCT Center), United States
The respective Centers of Excellence’s contacts and website links can be found here.
ACTIVITIES
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2022 |
OCT |
APEC CoE Training (Virtual) |
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Pharmaceutical and Medical Devices Agency (PMDA) with NCC , Japan |
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APEC CoE Training (Hybrid) |
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Peking University (Sep-Oct 2022) |
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KoNECT (Oct 2022) |
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2021 |
OCT |
APEC CoE Training (Virtual) |
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Korea National Enterprise for Clinical Trials (KoNECT), Korea |
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JUN |
APEC CoE Training (Virtual) |
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Peking University (PKU), China |
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JAN |
APEC CoE Training (Virtual) |
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Pharmaceutical and Medical Devices Agency (PMDA) with NCC, Japan |
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2020 |
OCT |
APEC CoE Training (Virtual) |
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Korea National Enterprise for Clinical Trials (KoNECT), Korea |
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JUN |
APEC Center of Excellence established |
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Korea National Enterprise for Clinical Trials (KoNECT), Korea |
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JAN |
APEC CoE Training (Japan) |
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Pharmaceutical and Medical Devices Agency (PMDA), Japan |
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2019 |
NOV |
APEC CoE Training (China) |
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Peking University (PKU), China |
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SEP |
APEC Pilot CoE Training (Korea) |
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Korea National Enterprise for Clinical Trials (KoNECT), Korea |
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JUL |
APEC Pilot Center of Excellence established |
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Korea National Enterprise for Clinical Trials (KoNECT), Korea |
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FEB |
APEC CoE Training (Canada) |
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The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States |
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JAN |
APEC CoE Training (Japan) |
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Pharmaceutical and Medical Devices Agency (PMDA), Japan |
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2018 |
SEP |
APEC CoE Training (China |
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Peking University (PKU), China |
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AUG |
APEC Center of Excellence established |
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The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States |
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APR |
APEC Pilot CoE Training (United States) |
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The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States |
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JAN |
APEC CoE Training (Japan) |
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Pharmaceutical and Medical Devices Agency (PMDA), Japan |
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2017 |
DEC |
APEC CoE Training (China) |
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Peking University (PKU), China |
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FEB |
APEC Centers of Excellence established |
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Pharmaceutical and Medical Devices Agency (PMDA), Japan |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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Peking University (PKU), China |
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JAN |
APEC Pilot Center of Excellence established |
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The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States |
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APEC CoE Training (Japan) |
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Pharmaceutical and Medical Devices Agency (PMDA), Japan |
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2016 |
JUL |
APEC Pilot CoE Training (China) |
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Peking University (PKU), China |
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MAR |
APEC Pilot CoE Training (Singapore) |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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2014 |
MAR |
APEC Pilot CoE Training (Singapore) |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |