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Regulatory Requirements for Pharmaceutical Products
A required course in the Certificate Programs Clinical Trials: Medical Device and Drug Development and Regulatory Affairs and Compliance.
Course Description
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.
Instructor
Textbook Information
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
Required Textbook(s):
A PRACTICAL GUIDE TO FDA'S FOOD AND DRUG LAW AND REGULATION 9781935065876
Meeting Schedule
Event Date Day Start Time End Time Location Room
START 09/25/2023 Monday --- --- Online (Access Begins) ---
END 12/03/2023 Sunday --- --- Online (Access Ends) ---