Committee for Non-Clinical Safety Evaluation of Pluripotent Stem Cell-derived Product
Activity Report

• Through the “AMED MEASURE” activities, consider safety evaluation methods which harmonize with international regulatory policy and which is important for research and development of pluripotent stem cell-derived product in order to gain a consensus globally.
• Validate Tumorigenicity tests and Pharmacokinetic Studies through conducting multi-site studies.

(*Multisite Evaluation Study on Analytical Methods for Non-clinical Safety Assessment of human-derived Regenerative Medical Products)