Biotechnology and the Regulatory Environment
BTMN 636 | 3 Credits
Course Desc: A comprehensive review of the role of regulation in biotechnology products and services development and commercialization. Emphasis is on the roles of the federal government, state government agencies, international bodies, and professional groups, especially the regulatory roles of the U.S. Environmental Protection Agency, Department of Agriculture, and Food and Drug Administration. Discussion covers human subject protection, good laboratory practices, and good manufacturing practices.
