Course Number: BIOL 539 (3.00 Units)
You will receive a comprehensive overview of the components necessary for creating a clinical trial report for a pre-market submission to the U.S. FDA. Concepts included are the development of timelines for submissions and the project management principles followed by Regulatory Affairs professionals employed in the biomedical industry. You will discuss the incorporation of clinical data into product labeling, best practices for negotiating with regulatory agencies, ethical considerations, statistical issues in submissions and post-market clinical study scenarios. The global perspective on pre-market submissions process will also be highlighted. Team projects based on case studies and real world examples will reinforce the overall course objectives.
Note: Click on the schedule number (i.e. E125-11103) to view more course information.
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