Agenda Speaker Biographies APEC Recording
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. Following the training, attendees will be able to:
- Describe the principles of CAR T cell therapy and basic regulatory considerations
- Define key terms and acronyms related to advanced therapies
- Explain the CMC best practices and concerns that have been seen in regulatory submissions
- List common critical quality attributes (CQA) and associated analytical methods
- Discuss common safety and quality challenges faced by CAR T cell manufacturers
Please note that this workshop is open to regulators only
For questions, please contact:
Bruno De Carvalho (bruno.decarvalho@usp.org)