BIO 405 - Regulatory Affairs and Safety Assessment (4)

An examination of governmental laws and regulations governing the safety of biological products, such as foods, drugs, medical devices and biologics, and basic approaches to assessing the safety of biological products. Use of toxicological methods to determine safety of biological products and concepts in risk determination and assessment. Development and evaluation of a series of in class assignments with class discussion and a capstone project performed with small student groups culminating as in-class presentations.

Prerequisite(s): General Introductory Biology Course, BIO 121/121L, BIO 122/122L, BIO 123/123L, or equivalent.
Component(s): 4 lecture units.
When Offered: W
Faculty: Dixon.