CLRA 510 - Introduction to Drug Development

Introduction to the pharmaceutical industry and the process of drug development. Drug development phases 1-4 are discussed. Regulatory requirements of the Food and Drug Administration are reviewed along with the content of the investigational new drug application (IND), the new drug application (NDA) and the marketing authorization application (international). The roles of investigator, coordinator, sponsor and monitor are discussed. Exposure to the skills necessary to function as a successful study monitor is given.

Credit Hours: 3 hrs
Grade Mode: Normal (A-F)

Typically offered Fall

Last Updated:
Course Rotation 9/2014

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