Description: Hours: Three hours lecture per week
Prerequisite: Admission to the Biotechnology & Bioinformatics, M.S. or the Biotechnology, M.S. & M.B.A. Dual Degree program
Description: An introduction to the foundational knowledge and skills necessary to successfully conduct clinical trials for new drugs, biologics, and medical devices, including in vitro diagnostics. Topics include a broad overview of the product development process in the pharmaceutical, biopharmaceutical, and medical device industries, the regulatory and operational requirements for clinical study setup and management, monitoring, data management, and closure of clinical trials, the principles of Good Clinical Practice (GCP), and the applications of quality control and quality assurance. The integration of quality assurance throughout the medical product development process will be discussed.
Units: 3.00
Grading: Letter Grade
| Session | Section | Class # | Type | Days | Time | Location | Instructor | Course Details [Key] |
|---|---|---|---|---|---|---|---|---|
| E1 | 1 | 2199 | LEC | T | 06:00 PM - 09:00 PM | Sierra Hall 2422 | Twinkle Christian |
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Key for Course Detail Icons
| = Course Open |
 = Course Closed |
= Course Details |
 = Textbook Info |
 = General Education |
= Extended University |
 = Service Learning |
= In Person |
 = Asynchronous Online |
 = Synchronous Online |
 = Synchronous/Asynchronous |
 = Blended |
 = No Cost Course Materials |
 = Low Cost Course Materials |