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

Presented by the Office of Regulatory Affairs and Quality, Duke University School of Medicine

Location: Trent Semans Center - Duke University School of Medicine, Great Hall | also available via WebEx

The Investigational New Drug (IND) Workshop
Speakers: Kristen Foss, PhD, RAC; Stephanie Pierce, PhD
June 13, 2017
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: Sarah Gemberling, PhD, RAC; Kelly Lindblom, PhD
June 14, 2017
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

Light refreshments will be served.

Register to attend in person or via WebEx. Register

The Office of Regulatory Affairs and Quality, in collaboration with the University of North Carolina at Chapel Hill, Wake Forest School of Medicine, and RTI International, are pleased to offer educational seminars as part of a regional Regulatory Forum, ReGARDD (ReGARDD.org). Educational seminars are aimed at bringing together academic researchers, industry, and regulatory experts to discuss ideas, lessons learned and develop strategies for navigating the complex regulatory pathways that accompany translational research.