2012-2013 Graduate Catalogue Archived Catalogue
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CLR 520 - Regulatory Affairs & Project ManagementCredits: (3)
In-depth study of regulations pertaining to biopharmaceutical and device development, including, but not limited study of INDs, NDAs, ANDAs, CANDAs, PLAs, CMC, submission processes, and financial/accounting (Sarbanes-Oxley) compliance. Studies the organization, responsibilities, and interactions between Regulatory Affairs and Project Management necessary to successfully manage pre-clinical and clinical research projects.
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