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 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?
Registration for the Fall 2025 program is now closed. Please check back soon or visit our Education and Training page and follow the instructions for joining our event subscription email list. Subscribers will be notified about future programs.
Weekly Schedule & Topics
| Week | Topic |
|---|---|
| Week 1 | Drug Development and FDA Meetings |
| Week 2 | Applicability of FDA Drug Regulations to Clinical Studies |
| Week 3 | IND Content, Format, Review and Maintenance |
| Week 4 | Medical Device Development and FDA Meetings |
| Week 5 | Applicability of FDA Device Regulations to Clinical Studies |
| Week 6 | IDE 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 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.