Biologics Development: A QA/Regulatory Overview
RGA6200 / 4 q.h.
Formerly RA 3200.
Offers students an opportunity to conduct a comprehensive and up-to-date analysis of the post-reform FDA Center for Biologics Evaluation and Research (CBER) and the complete U.S. biological product approval process, from preclinical testing to postmarketing regulatory requirements. Includes both CBER official and industry expert perspectives on quality assurance issues and related regulatory topics in successfully bringing biologics to market, as well as current good manufacturing practice regulations to assure quality of marketed products.
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