Regulatory Requirements for Pharmaceutical Products

This course presents a detailed overview of the regulatory requirements for the discovery, development, registration 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 about all these disciplines to take a product to market and maintain it on the market.

We will 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 preparing Food and Drug Administration (FDA) submissions.

You will learn where to find regulatory information on the FDA website to support all these activities.