Apr 19, 2024  
2013-2015 University Catalog 
    
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2013-2015 University Catalog [ARCHIVED CATALOG]

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BIOL 539 - Clinical Trials Project Management: Pre-Market Submission Process for Clinical Trials (3)

Prerequisites: BIOL 576, or equivalent; BIOL 538 . Clinical trial reports for pre-market submission: developing timelines; project management principles; product labeling; best practices for negotiating with regulatory agencies; ethical considerations; statistical issues in submissions; post-market clinical study scenarios. Team projects based on case studies/real world examples.


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