Principles and Practice of Biotechnology:
Regulation and Ethics

Year 1: Fall semester, 2 credits

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Biotechnology Regulation & Ethics, in conjunction with its partner course, Principles and Practice of Biotechnology: Intellectual Property, Patents and Licensing, is designed as an introductory survey course of the political and legal issues that have driven the development of the biotechnology industry.

Special emphasis is given to the following topics: FDA regulation of new drug/device/biologics development and of gene therapy; EPA/USDA regulation of agricultural applications of biotechnology; federal regulation of genetic testing services; politics and regulation of embryonic stem cell research.

Students should come away with an enhanced ability to understand how these factors interact with business and finance to influence the formation and growth of biotechnology companies. Students will be introduced to the ethical issues that help shape public policy regarding applications of biotechnology.

After the successful completion of this course, students will be able to:

• Understand the structure of the US legal and regulatory system, and identify the key steps in the development of regulations that affect biotechnology product development and deployment.
   
  
• Identify the key areas of ethical concern regarding research and applications using biotechnology.
   
  
• Identify and understand the source and content of the key laws and regulations governing biotechnology research and its agricultural and medical applications.