Regulatory Requirements for Pharmaceutical Products (English)

Course Information

Important Notice

Effective August 19, 2016 this course will no longer be available. Some of the content is out-of-date and since the course relies heavily on Adobe Flash technology, is not completely viewable on many smartphones and tablets. If you are interested in this topic, please visit https://ce.uci.edu/areas/?topic=ls for a listing of up-to-date courses offered by UCI’s Division of Continuing Education. We apologize for the inconvenience.

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
Keywords: Pharmaceutical products requirements,pharmaceutical product manufacturing,product development process,commercialization,pre-clinical evaluation,pharmaceutical industry requirements,good manufacturing
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