The Office of Regulatory Affairs and Quality (ORAQ) is committed to providing education and training on the regulation of investigational medical products by the United States Food and Drug Administration (FDA).
We offer educational seminars, workshops, and course lectures on topics related to regulatory strategy, product manufacturing, and regulatory submissions. In addition to sponsoring our own events, we also host speakers from industry, academia, and government agencies. The goal of our events is to provide education on an ever-changing regulatory landscape and to share ideas and lessons learned to aid the development of new drugs, biologics, and devices.
In addition to education and training events, we also conduct the Regulatory Affairs Training Program for individuals interested in exploring regulatory affairs as a profession and Sponsor and Investigator Training for all Duke faculty that sponsor regulatory applications with the FDA.
Interested in learning more about regulatory affairs and quality assurance? Please see the list of our upcoming events, sample education and training opportunities, and past events below.
Upcoming Events
There are currently no upcoming events. Check back soon or join our event subscription list below.
Event Subscription
To be notified of upcoming education and training events hosted by ORAQ please follow the instructions below to subscribe.
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Request a Speaker
Are you interested in having an ORAQ staff member speak at an upcoming seminar, workshop, or course lecture? Please complete our online form to request a speaker. ORAQ staff will review each request and follow up within five business days.
Investigational New Drug (IND) Workshop
This workshop will offer best practices when conducting clinical trials using FDA-approved and unapproved drugs and biologics. It will give an overview of the IND application process and the regulatory obligations of the sponsor-investigator once an IND is filed with the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation. This workshop will address the following questions (and more):
- What is an investigational drug?
- Do I need an IND for my investigation?
- When should I consider having a Pre-IND meeting with the FDA?
- What information needs to be included in my IND application?
- What are the reporting requirements once my IND is effective?
Investigational Device Exemption (IDE) Workshop
This workshop will offer best practices when conducting clinical trials using FDA-approved and unapproved devices. It will give an overview of the regulation of medical devices, the IDE application process, and the obligations of the sponsor-investigator once the IDE application is approved by the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation. This workshop will address the following questions (and more):
- What is FDA’s approach to regulating the commercialization of medical devices?
- How are nonsignificant risk (NSR)/significant risk (SR) determinations made?
- What is the difference between an abbreviated IDE and a “full” IDE?
- What information needs to be included in an IDE?
- What are the reporting requirements once my IDE is approved?
Medical Device Development
This seminar will offer an overview of the regulatory considerations for the development of medical devices. It will give an overview of how to classify your medical device, determine the applicable regulatory requirements and commercialization options, develop a strategy based on applicable regulations, meet with the FDA, and apply for FDA approval for a clinical study testing a significant risk medical device. Case scenarios will be presented to enhance learning and stimulate audience participation.
Course Lectures
ORAQ staff are available to present lectures for undergraduate or graduate level courses. Previous topics of course lectures have included: an overview of FDA regulation of medical devices and/or drugs, personalized medicine and the FDA, regulatory intelligence, monitoring, and GMP/GLP regulations.
Special Topics
ORAQ staff are available to present lectures on a number of special regulatory topics at conferences, workshops, symposia, or small staff meetings. Possible topics include FDA Regulation of Software, Good Laboratory Practices, In Vitro Diagnostic Devices, and Investigational Tobacco Products.