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Certificate in Regulatory Affairs: REG 5000 Introduction to US Food and Drug Law

August 26 @ 5:00 pm - 7:00 pm

Innovators Start Here: KGI Unveils New Brand - Keck Graduate Institute

This course is designed to provide a broad overview of the United States regulatory system, with some European Union structure and regulation highlights. Students will gain a basic understanding of how the FDA regulates the approval of various products and how this has changed over time, as well as the necessary inputs companies must be aware of when applying for regulatory approvals in the USA. (ALS 362)

Semester: Fall 1/Spring 1
Credit(s): 1.5
Instructor(s): Larry Davis


Program Overview

The Certificate in Regulatory Affairs is an online, part-time 6-credit program for working professionals. The certificate aims to provide participants with regulatory affairs experience for all FDA-regulated product classes (drugs, biologics, and devices).

What You’ll Learn

Participants will participate online interactive courses that focus on the regulatory challenges that applied life science companies face today and be able to present requirements to industry management and regulatory site personnel, including documentation, and accepted industry practices. Topics and skills include:

  • Understand regulatory background, principles and best practices in developing and managing regulatory systems within the biopharmaceutical industry.
  • Comprehend and assess the documentation and regulatory requirements necessary at each stage of the regulatory submission and review process.
  • Present requirements to industry management and regulatory site personnel, including documentation, and accepted industry practices.
  • Extended understanding of the language, logic and critical thinking skills, to make regulatory decisions and develop strategies regarding product development and submissions.
  • Be conversant in drug and biologic product development and licensure, including product development cycle, testing and labeling criteria, treatment regimen, adverse event assessment, documentation, efficacy response assessment, pre- and post-approval documentation requirements.

Who Should Apply

Life science professionals with applied life science experience with an interest in gaining knowledge of regulatory affairs as it related to the bioscience and healthcare industries.

Format: Online
Duration: Nine Months
Time: Early Evening (PST)
Cost: $1,041 Per Credit, Degree total 6 credits $6,240


For More Information:
Tracy Kurzy
Director, Corporate Education
(909) 607-0382
[email protected]




August 26
5:00 pm - 7:00 pm
Event Category: