Advanced therapies (cell, tissue and gene therapy products or regenerative medicine products) hold the promise to treat and cure medical conditions and diseases that currently have limited or no effective therapeutic options. Both the technical and regulatory sciences are rapidly evolving with many economies establishing a comprehensive regulatory framework that will be pro-innovation yet safeguard public health and safety. The goal of the PWA is to facilitate and implement strategies to stimulate and promote prospective regulatory convergence in applying scientific principles and best practices to ensure and enhance the safety, quality and efficacy of advanced therapy product development throughout the product life cycle.
CO-CHAMPIONS
- Health Sciences Authority (HSA), Singapore
- US Food and Drug Administration (US FDA), United States
SUB-CHAMPION
- Biotechnology Innovation Organization (BIO)
The PWA Co-Champions and Sub-Champion’s contacts can be found here.
CENTERS OF EXCELLENCE
- Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
- Northeastern University (NEU), United States
- United States Pharmacopeia (USP), United States
The respective Centers of Excellence’s contacts and website links can be found here.
ACTIVITIES
| 2022 |
JAN |
APEC CoE Training (Virtual) |
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United States Pharmacopeia (USP), United States |
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APR |
APEC CoE Training (Virtual) |
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Northeastern University (NEU), United States |
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SEP |
APEC CoE Training (Virtual) |
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Northeastern University (NEU), United States |
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DEC |
APEC CoE Training (Latin America) |
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Northeastern University (NEU), United States |
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| 2021 |
MAY |
APEC Center of Excellence established |
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United States Pharmacopeia (USP), United States |
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MAR |
APEC Pilot CoE Training (Virtual) |
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United States Pharmacopeia (USP), United States |
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2020 |
JUN |
APEC Pilot Center of Excellence established |
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United States Pharmacopeia (USP), United States |
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2019 |
OCT |
APEC Center of Excellence established |
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Northeastern University (NEU), United States |
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AUG |
APEC Center of Excellence established |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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JUL |
APEC Pilot CoE Training (United States) |
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Northeastern University (NEU), United States |
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2018 |
JUL |
APEC Pilot CoE Training (Singapore) |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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FEB |
APEC Pilot Center of Excellence established |
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Northeastern University (NEU), United States |
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2017 |
JUL |
APEC Pilot CoE Training (Singapore) |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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2016 |
AUG |
APEC Pilot Center of Excellence established |
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Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore |
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Establishment of Advanced Therapies PWA |