BIOT 105Survey of Regulatory Affairs

Catalog

PREREQUISITES: Program Chair’s Approval. CATALOG DESCRIPTION: This course provides an entry level introduction to the laws and regulations that govern the development, marketing and commercial distribution of drugs,biological and medical device products and how they relate to the pharmaceutical, biotechnology and medical device industry. This course in intended to provide individuals with a greater understanding of regulatory affairs, specifically providing an understanding of how their actions are controlled by regulations and how to interact with FDA or global regulatory agencies.