You must be (or become) a member to register
Standard membership is currently $50
Each Workshop registration is $95
This workshop series is a comprehensive overview of regulatory requirements for development, manufacture, marketing and compliance for device and drug/biological human medicinal products in the US, EU, and other countries. It is especially useful for those studying for the RAC or FRA certification exams, but also is valuable for anyone interested in learning more about WHY the industry operates as it does. Each session in the series features a lecturer with relevant industry or other "field" experience to illustrate the concepts discussed.
Registration enables you to view the recordings of the workshop sessions.
The series will run Tuesday evenings from June 9-October 6, 2026, 6-8 pm (US Eastern time).
NCRAF has offered this series annually since some time in the prior millenium. Seriously.
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The Duke University School of Medicine’s
Office of Regulatory Affairs and Quality (ORAQ)
invites you to join the Fall 2026 ORAQ Regulatory Affairs Training Program
a six-week online course designed to give you a strong foundation in pre-market FDA
regulatory processes for drugs, biologics, and medical devices.
What You’ll Gain:
A clear understanding of drug, biologic, and device development
Practical knowledge of INDs and IDEs—how to prepare, format, and maintain them
Tips for successful FDA meetings
A certificate of completion to showcase with your resume
Program Details:
Start Date: September 11, 2026 at 9:00 AM ET
Format: Six 1-hour Zoom lectures (recordings available for 12 weeks)
Cost: $200 (credit card only; non-refundable)
Certificate: Earn it by completing a quiz
Open to Everyone – No Experience Required!
Have questions? Check out our FAQ page.
Registration closes September 8th, 2026 at 11:59 PM ET.
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See "Upcoming Events" at right (desktop) or below (phone) for details and registration for all upcoming NCRAF events.
Become an NCRAF member to enjoy significant discounts for registration at most NCRAF events, and to be notified of all upcoming events!
Most NCRAF events are free for our members - and most events are available for hybrid/remote access.
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