(418a) Opq Initiatives to Advance Pharmaceutical Quality through Innovative Approaches (invited talk)

My presentation will highlight the various programs we implementing in CDER (i.e., KASA, ETP, FRAME, Alternate Tools for Inspection, QMM, etc.) into one talk to facilitate implementation of new technologies in bio-pharmaceutical manufacturing and also enhance our assessment and oversight processes to enable efficient and effective interactions with industry to supply safe, high quality and affordable medicines to the American public. Furthermore, highlight how during the COVID-19 pandemic, we have modified the tools for assessment of facilities in view of travel limitations to enable OPQ continue to assess applications and take actions to ensure critical medicines made available to the public. Also identify our collaborative efforts with other Regulators in the use of new technologies and ways of working to accelerate availability of critical medicines worldwide post-pandemic.