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, devices and biologics.
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-Investigator Training for all Duke faculty that sponsor regulatory applications.
Interested in learning more about regulatory affairs and quality assurance? Please see the list of our upcoming events and sample education and training opportunities below.
FDA Oversight of In Vitro Diagnostic Devices
Sponsored by the Medical Center Library and DOCR
Speaker: Sarah Gemberling, PhD, RAC
Date: April 25, 2018
Location: Duke North 2002
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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.
Sample Education and Training Opportunities
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.
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.
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 Mobile Medical Applications, Good Laboratory Practices, In Vitro Diagnostic Devices, and Investigational Tobacco Products
The Investigational Device Exemption (IDE) Workshop
Speakers: Kelly Lindblom, PhD, RAC and Sarah Gemberling, PhD, RAC
April 11, 2018
The Investigational New Drug (IND) Workshop
Speakers: Daniel Tonkin, PhD, RAC and Stephanie Pierce, PhD, RAC
April 10, 2018
Digital Health Rules and Regs: An Overview of FDA Guidelines
Speaker: Kelly Lindblom, PhD, RAC
March 20, 2018: Webcast
Developing Monitoring Plans for Investigator-Initiated Clinical Trials
Speaker: Sandra SAM Sather, MS, BSN, CCRA, CCRC
November 14, 2017: Webcast
Modernizing the Clinical Research System: Insights from the Former FDA Commissioner
Speaker: Rob Califf, MD, MACC, UNC Campus
October 2, 2017
Best Practices for the Preparation, Submission and Maintenance of Sponsor-Investigator INDs and IDEs
The IND Workshop: Kristen Foss, PhD, RAC and Stephanie Pierce, PhD
June 13, 2017: Webcast
The IDE Workshop: Sarah Gemberling, PhD, RAC and Kelly Lindblom, PhD
June 14, 2017: Webcast
ReGARDD Medical Device Seminars
Tips for Success in Medical Device Premarket Submissions to FDA: Heather Rosecrans, FRAPS
The Medical Device Reimbursement Life Cycle: Jo Ellen Slurzberg
April 12, 2017