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Note: This course is not available for the current semester.
Course No: 81.555; Last Offered: No Data;
Course Description
This course examines how drugs, biologics and cellular therapies are evaluated, manufactured and sold in the United States. cGMP's, clinical trials, INDA, NDA, ANDA, PLA, ELA, validation, Q.A., Q.C., interactions with FDA staff and with company product and process development, regulatory affairs, drug metabolism, medical affairs, and production are covered in a lecture and project format.
Prerequisites & Notes
- Prerequisites:
- Special Notes:
- Credits: 3;
Questions About This Course?
Contact the Advising Center at 978-934-2474 or
Continuing_Education@uml.edu
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