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Apr 20, 2024
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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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