기본 정보
연구 분야
프로젝트
논문
구성원
review|
hybrid
·인용수 6
·2023
Non-clinical, quality and environmental impact assessments of cell and gene therapy products: Report on the 5th Asia Partnership Conference of Regenerative Medicine - April 7, 2022
Toshimitsu Tanaka, Hiroshi Karasawa, Masahiko Yasumoto, Byung Hyune Choi, R. Shihman Chang, M. Komuro, Masaaki Miyano, Yuu Moriya, Sasikumar Muthusamy, Shingo Okubo, Koji Takakura, Yoshie Tsurumaki, Takeshi Watanabe, Karen Wen, Tomohiro Yoneda, Ta-Tung Yuan, Masayuki Nomura
IF 3.2Cytotherapy
초록

The 5th Asia Partnership Conference of Regenerative Medicine (APACRM) was held online on April 7, 2022 to promote regulatory harmonization of regenerative medicine products throughout Asia. The recognition of domestic regulatory guidelines within each country and region and the underpinning rationales are important initial steps toward the harmonization of regulations. The 5th APACRM featured open dialog regarding non-clinical, quality and environmental impact assessment settings for cell and gene therapy products through presentations from the industry and panel discussions with regulatory agencies. The latest updates on regenerative medicine fields in each country and region were also introduced. This paper summarizes the proceedings of the 5th APACRM for public dissemination to foster future discussion.

키워드
HarmonizationGeneral partnershipDialog boxRegenerative medicineQuality (philosophy)Political scienceBusinessEngineering ethicsMedicineEngineering
타입
review
IF / 인용수
3.2 / 6
게재 연도
2023