Product Development-Premarket

Course Code: REGA 5021

Academic Year: 2019-2020

This course focuses on the components and phases of health care product development, with an emphasis placed on pharmaceuticals, and the Canadian and international legislation and regulations applicable to bringing a new medication to commercialization. Students gain knowledge in overall product development, in preclinical studies and in requirements for clinical studies. Pertaining regulations and submission process will be discussed.