Open Stage Seminar Oct. 12 (Fri.)  14:30 ~ 15:00

Forum for Innovative Regenerative Medicine

Tatsuo Heki

Fujifilm Corporation

Yutaka Yanagita

Astellas Pharma

ISO, the international standard – its contributions to regenerative medicine industrialization.

ISO (The International Organization for Standardization) is an international standards developing organization composed of representatives from 161 national standards organizations, as of July 2018. Usage of ISO standards in medical industry is currently limited to areas such as medical devices and medical laboratories. Further, ISO standards themselves were not familiar in pharmaceutical industry, because regulations covered most of the requirements for its products. With regard to regenerative medicine, however, United States is in the direction of making use of ISO standards in regulatory reviews. The session will cover activities in ISO/TC 276 (Biotechnology)which represents this movement.

Window Close