Certificate in Regulatory Affairs

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).

Why Choose Keck Graduate Institute?

If you’re not familiar with KGI, we offer breakthrough approaches to education in healthcare, biotech, and applied life sciences. Our courses are taught by experts with real-world professional experience with some of the top names across healthcare and science organizations and companies.

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.

What You’ll Gain

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.