Education and Training

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.


Upcoming Events

 

Digital Health Rules and Regs: An Overview of FDA Guidelines

Speaker: Kelly Lindblom, PhD, RAC
Date: March 20, 2018
Time: 9:00am-10:00am
Location: Duke North 2003
Registration: http://bit.ly/MAGmobilehealthguidelines

This seminar will give an overview of FDA’s approach to regulating mobile medical apps and software. Types of mobile apps/software that are not subject to FDA regulation will be reviewed. Guidance will be provided on how to determine the risk level of your mobile app/software, and an overview of the regulatory requirements for testing mobile apps in human subjects will be provided. Participants are encouraged to bring a mobile device to participate in case scenarios.

 

Best Practices for the Preparation,
Submission, and
Maintenance of Sponsor-Investigator
INDs and IDEs​

Presented by the Office of Regulatory Affairs and
Quality
April 10-11, 2018
Trent Semans Center | Great Hall

The Investigational New Drug
(IND) Workshop

Speakers:
Daniel Tonkin, PhD, RAC
Stephanie Pierce, PhD, RAC

April 10, 2018
1:00 PM – 4:00 PM


 

This workshop will​​​​​:

  • Define an investigational drug, including off-label use of FDA approved drugs

  • Provide guidance on determining when the IND regulations apply to research studies

  • Discuss the preparation and submission of IND applications to FDA

  • Review maintenance and safety reporting requirements

  • Encourage participant discussion of case scenarios
     

The Investigational Device Exemption
(IDE) Workshop

Speakers:
Kelly Lindblom, PhD, RAC
Sarah Gemberling, PhD, RAC

April 11, 2018
9:00 AM – 12:00 PM


 

This workshop will:

  • Discuss FDA’s approach to regulation of devices in clinical studies and for marketing.

  • Provide guidance on when the IDE regulations apply and discuss possible exemptions

  • Review significant risk and non-significant risk device studies

  • Discuss the preparation, submission, and maintenance of IDE applications

  • Encourage participant discussion of case scenarios

 

Directions: Parking for the Trent Semans Center can be found in the Duke
Medicine Circle Parking Garage I on Trent Drive. Parking is $2 per hour/$8 per
day. Please see walking directions below.
http://www.hl7.org/documentcenter/public_temp_D3559507-1C23-BA17-0C39D846224B2D95/calendarofevents/other/DukeWalk_directions.pdf

 

IND Workshop Registration   IDE Workshop Registration 

 

 

To be notified of upcoming education and training events hosted by ORAQ, please subscribe below.

Event Subscription

 

 

 


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.

Request a Speaker

 

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.


 
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 Mobile Medical Applications, Good Laboratory Practices, In Vitro Diagnostic Devices, and Investigational Tobacco Products.

Past Events 

 

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