CTA 5000 - Introduction to Drug and Device Development

This course introduces the student to the pharmaceutical and medical device industry and the process of drug and device development. Drug Development Phases I-IV are discussed. Preclinical (animal) research, regulatory requirements, are reviewed along with the content of the Investigational New Drug Application (INDA), the New Drug Application (NDA), Pre-Market Approval (PMA), and the Marketing Authorization Application (international). The roles of the Investigator, Study Coordinator, Sponsor, and Monitor are discussed. Students are exposed to the skills necessary to function as a mid-level research employee.

Credits: 3 hours