Mar 28, 2024  
2016-2017 University Catalog 
    
2016-2017 University Catalog [ARCHIVED CATALOG]

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


Covers clinical trial reports for pre-market submission: development of 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.

Prerequisites: BIOL 576 , BIOL 538 .



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