Course Description:
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. Who Should Participate:QA Manager, QA Staff, QC Chemist, QC Manager, R&D, Regulatory, Student
The live version of this recording took place May 2023
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
Jared R. Auclair, Ph.D.,
Vice Provost Research Economic Development and Director of
Bioinnovation in the Office of the Provost
ELVIRA ARGUS, Ph.D
CMC Biological Reviewer
FDA CBER
ALEXANDRA BEUMER SASSI, Ph.D., RAC
Senior Director CMC & Quality
Voisin Consulting Life Sciences (VCLS)
BEN CLARKE, Ph.D.
Senior Scientist, Global Biologics
USP
SRINIVASAN KELLATHUR, Ph.D.,
Regulatory policy lead APAC
Roche
SHUYUAN ZHANG, Ph.D.,
CTO
Forecyte Bio
MEHRSHID ALAI, Ph.D.
VP of Global Regulatory CMC
Kite Pharma
LUCAS CHAN, Ph.D., FRSB
Scientific Founder & CSO
CellVec Pte Ltd