Program Overview

Regulatory Affairs for Cell and Gene Therapy

The Certificate in Regulatory Affairs for Cell and Gene Therapy trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students will learn how to manage everything from pre-clinical IND-enabling studies to product licensure, and on into post-approval lifecycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, ethics, CMC, and international market requirements for cell and gene regulatory affairs.

Degrees Offered

• Certificate
  • Availability: Part-Time
  • Location: Online

Application Requirements

Online Program

Please refer to the application requirements and deadlines for the online program.

Program Details

The program focuses on training leaders in the field of regulatory affairs for cell and gene therapy, covering a wide range of topics including:

• Pre-clinical IND-enabling studies
• Product licensure
• Post-approval lifecycle management
• Post-approval change reporting categories
• Accelerated approval mechanisms
• Managing agency inspections
• Ethics
• CMC
• International market requirements for cell and gene regulatory affairs