The USP-APEC Center of Excellence for Advanced Therapies Virtual Training will convene regulators from APEC member economies to build regulatory capability to review chemistry, manufacturing and control (CMC) elements of dossiers for chimeric antigen receptor (CAR) T cell therapy products. This training is part of the Advanced Therapy Priority Work Area under the APEC Regulatory Harmonization Steering Committee (RHSC) to promote prospective regulatory convergence for advanced therapy products, including cell and gene therapies. It is designed by the U. S. Pharmacopeia (USP), a global standard-setting body, in collaboration with the APEC RHSC.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
QA Manager, QA Staff, QC Chemist, QC Manager, R&D, Regulatory, Student