The Office of Regulatory Affairs and Quality will be presenting two workshops from April 10-11, 2018 at the Trent Semans Center, Great Hall. 

The Investigational New Drug (IND) workshop will take place on April 10 from 1-4 p.m. with Daniel Tonkin and Stephanie Pierce presenting. 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 will take place on April 11 from 9 a.m. until 12 p.m. with Kelly Lindblom and Sarah Gemberling presenting. 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 at both of these workshops. Please register here.