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- biol-539 - clinical-trials-project-management-pre-market-submission-process-for-clinical-trials
California State University-Fullerton Course Info
Fullerton, California
Course Info
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BIOL 539
Clinical Trials Project Management: Pre-Market Submission Process for Clinical Trials
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
Units: 3.0
Prerequisites:
BIOL 538 - Clinical Trials Project Management: Managing Clinical Trials
and
BIOL 576 - Regulatory Affairs for the Biotechnology Industry