Regulatory Requirements for Pharmaceutical Products (English)

Course Information

This course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization; product characterization and pre-clinical evaluation; pharmaceutical industry requirements; clinical trial requirements, good manufacturing practices (GMPs); good laboratory practices (GLPs); FDA inspections, labeling, and advertising of medical products; and preparing Food and Drug Administration (FDA) submissions.

UNEX Life Sciences Dept. | University Extension Sch. | University of California, Irvine
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