Regulatory Compliance Course Calendar, Northwestern University School of Professional Studies - Northwestern School of Professional Studies

Program Courses

Please note that course schedules may be amended due to low enrollment, faculty availability, and/or other factors.

Online Sync Sessions are an integral part of the online learning experience. Additional information about learning concepts and assignments may be discussed and sync sessions offer valuable opportunities for students to interact with their faculty and peers during the term. We encourage all students to attend live, but if they are unable to, sync sessions will be recorded and posted within Canvas to allow for an asynchronous model of success as well.

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.