EECS X445.26

Regulatory Requirements for Pharmaceutical Products

A required course in the Certificate Programs Clinical Trials: Medical Device and Drug Development and Regulatory Affairs and Compliance.

This course presents a detailed overview of the regulatory requirements for the discovery, development, and commercialization of pharmaceutical products (drugs and biologics). 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) and inspections, labeling medical products and writing Food and Drug Administration (FDA) submissions.

Approximate Cost $735
Format Online
Duration 10 Weeks
Total Credits 3


4/1/2024 - 6/9/2024
Weeks 10
Delivery Online
Fee $735
Status Closed


6/24/2024 - 9/1/2024
Weeks 10
Delivery Online
Fee $735
Status Open