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Regulatory Requirements for Pharmaceutical Products

A required course in the Certificate Programs in Medical Product Development, and Clinical Trials: Medical Device and Drug Development; and a prerequisite in the Specialized Studies Program in Regulatory Affairs Management.

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.

  • Details
  • $735
  • September 27, 2021 to December 05, 2021
  • Delivery Mode: Online
  • Reg#: 00198
  • ID/Units: EECS X445.26  (3.00)
    ( Section 1 )
  • Quarter: FALL 2021

Instructor


Erin Messer, PharmD, MBA serves as a Faculty Program Advisor for Independence University school of Healthcare – Allied Health, and an adjunct instructor for the United Career Institute. She has over 10 years of experience working in the pharmaceutical industry, including drug formulation, development and regulatory submission.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

Optional Textbook(s):

A PRACTICAL GUIDE TO FDA'S FOOD AND DRUG LAW AND REGULATION
Book - ISBN: 9781935065708
Kenneth R. Pina & Wayne L. Pin, 5 ed, The Food and Drug Law Institute

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START09/27/2021Monday------Online (Access Begins)---
END12/05/2021Sunday------Online (Access Ends)---