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 2025 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 October 15, 2025 at 9:00 AM ET.

Note: We strongly recommend that you use your personal email address for registration to avoid access issues with Google Suite or Box.
 

Program Details

  • Start Date: October 17, 2025
  • End Date: November 21, 2025
  • 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) throughout, including after daylight savings ends on November 2
     

Weekly Schedule & Topics
Week Date Topic
Week 1 October 17, 2025 Drug Development and FDA Meetings
Week 2 October 24, 2025 Applicability of FDA Drug Regulations to Clinical Studies
Week 3 October 31, 2025 IND Content, Format, Review and Maintenance
Week 4 November 7, 2025 Medical Device Development and FDA Meetings
Week 5 November 14, 2025 Applicability of FDA Device Regulations to Clinical Studies
Week 6 November 21, 2025 IDE Preparation, Submission, and Maintenance

Note: All sessions begin at 9:00 AM Eastern Time (ET). Daylight savings ends November 2, 2025.
 

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 all six post-lecture quizzes and receive a certificate of completion—a great addition to your resume or LinkedIn profile.
 

Questions?

Please visit our page for frequently asked questions.