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Georgetown University


Detailed Course Information


Fall 2017
Jan 21, 2018
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Information Select the desired Level or Schedule Type to find available classes for the course.

MPRA 600 - The Reg. of Pharmaceuticals
This course offers a comprehensive overview of the development of pharmaceuticals and relevant regulations in preclinical programs, clinical research, regulatory submissions, and post-marketing surveillance. Students review FDA regulations for nonclinical testing, clinical testing, good laboratory practices, and the marketing of pharmaceuticals. Related laws such as the Prescription Drug User Fee Act (PDUFA) are reviewed in depth. Students learn to complete processes such as the FDA’s Investigational New Drug Application (IND) and New Drug Application (NDA). By the end of this course, students will understand how to adhere to regulatory and compliance requirements f

3.000 Credit hours
3.000 Lecture hours

Levels: MN or MC Graduate
Schedule Types: Distance, Seminar

Prof StudiesRegulatory Affairs Department

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