Course Schedule

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QARS 460-DL : Drug and Biologics Regulations


Description

Students in this quality systems course discuss current policies and guidelines under which pharmaceutical, biological and medical device products are developed for human use and regulated while in commerce. Topics include regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, legal and ethical issues, and biological products. Students examine the newly implemented steps to harmonize international regulations. Students who complete this course will be prepared to research, identify and track the status of the regulations and guidance documents that impact the drug and/or biologics life cycle, as well as serving as valuable cross-functional team members representing regulatory affairs in a clinical operations setting.

Quality Systems and Clinical Research track course.


Winter 2023
Start/End DatesDay(s)TimeBuildingSection
01/03/23 - 03/18/23Optional Sync Tu
7 – 9:30 p.m. 55
InstructorCourse LocationStatusCAESAR Course ID
Beirne, Carol
Online
Open
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