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NOV 17, 2016 9:00 AM PST

From bench to BLA - a review of common regulatory questions

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Abstract

This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase.  Participants will learn what to look for in RUO and translational materials to ease the transition to the clinic including GMP and USP guidelines, what to consider when preparing for a clinical trial or a marketing application and common regulatory findings in cell therapy submissions that have the potential to delay approval. The panel will also discuss recent initiatives that have been put in place by regulators in different regions to accelerate cell therapy commercialization.
 


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