410.679 Practicum in Bioscience Regulatory Affairs (Open only to Students in MS BSRA)

This integrative case-based course will focus on applying knowledge gained from previous courses in the MS Bioscience Regulatory Affairs program to actual cases from the U.S. Food and Drug Administration. For each case, students will assume the role of either a regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication.
This course is only open to students in the MS in Bioscience Regulatory Affairs who have completed 8 courses. This course is intended to be either the 9th or 10th course in the program.

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