ORAQ Regulatory Affairs Training Program

Are you aiming for an entry-level role in pharmaceuticals or medical technology? Do you want to strengthen your resume with in-demand regulatory affairs expertise?

The Office of Regulatory Affairs and Quality invites you to enroll in the Fall 2026 ORAQ Regulatory Affairs Training Program—a dynamic, beginner-friendly course designed to give you a solid foundation in premarket FDA regulatory processes for drugs, biologics, and medical devices.


What You’ll Learn

By the end of this program, you’ll walk away with:

  • A clear understanding of drug, biologic, and medical device development
  • Practical knowledge of INDs and IDEs—including their content, format, and maintenance
  • Proven strategies for conducting successful meetings with the FDA

Whether you're a student, recent graduate, or professional exploring a new path, this program is open to everyone—no prior experience required!
 

How to Register? 

Click here to register now: Register 

Registration closes September 8, 2026 at 11:59 PM ET.
 

Program Details

  • Start Date: September 11, 2026
  • End Date: October 16, 2026
  • Time: 9:00 AM ET – 10:00 AM ET once each Friday
  • Format: Six weekly 1-hour Zoom lectures
  • Access: Recordings available for 12 weeks post-program (view-only); slides downloadable
  • Time Zone: Eastern Time (ET)
     

Weekly Schedule & Topics 

WeekDateTopic
Week 1September 11, 2026Drug Development and FDA Meetings
Week 2September 18, 2026Applicability of FDA Drug Regulations to Clinical Studies
Week 3September 25, 2026IND Content, Format, Review and Maintenance
Week 4October 2, 2026Medical Device Development and FDA Meetings
Week 5October 9, 2026Applicability of FDA Device Regulations to Clinical Studies
Week 6October 16, 2026IDE Preparation, Submission and Maintenance 

Cost

The cost to participate in the program is $200 payable by credit card only. No refunds will be provided after registration.
 

Certificate of completion

Complete the program quiz and receive a certificate of completion—a great addition to your resume or LinkedIn profile. 
 

Questions?

Please visit our page for frequently asked questions.