PHRA 301 - Introduction to Pharmaceutical Regulatory Affairs

This course covers in detail the FDA’s requirements and process for approving new pharmaceuticals/biopharmaceuticals. The topics covered in this course include the organization of the FDA, pharmaceutical regulatory law, types of regulatory approval pathways, product labeling, protection for human research subjects, patent and regulatory marketing exclusions, forces that impact the drug, validation, FDA’s partnership with the United States Pharmacopeia and the importance of building quality assurance into the drug development process will also be covered. Typically offered in Fall
Level: UG
Credit Hours: 3

Ferris Equivalencies:

Department: PHAR