10:30 a.m.-12:00 p.m.
An informal time to meet with MEDx leadership to learn more about MEDx, an initiative between the School of Medicine and Pratt School of Engineering, held every other week at NOSH (1st floor, Trent Semans Center) or Twinnie's (1st floor, FCIEMAS). For more information, contact Kelly Long.
Thursday, March 22
Engineering Devices to Treat Epilepsy
Presenter: Brian Litt - University of Pennsylvania
Brian Litt University of Pennsylvania Thursday, March 22 12:00 - 1:00 Bryan Research Building, Rm 103
Tuesday, April 10
The Investigational New Drug (IND) Workshop
Presenter: Daniel Tonkin, PhD, RAC & Stephanie Pierce, PhD, RAC
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
Wednesday, April 11
The Investigational Device Exemption (IDE) Workshop
Presenter: Kelly Lindblom, PhD, RAC & Sarah Gemberling, PhD, RAC
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