Upon completion of this course, the student should be able to:

1. Explain the Food and Drug Administration ’s (FDA) function, structure, and history of important legislation.
2. Summarize the purpose, substance and effects of “current Good Practices” (cGxP).
3. Explain the Pre-Clinical Development process.
4. Interpret the requirements for bringing biotechnology products to market.
5. Plan the business and regulatory activities that should occur when and after a biotechnology product is approved for market.
6. Utilize techniques for maintaining effective communications with regulators and business professionals.