ORAQ Will Hold Workshop This Week
The Office of Regulatory Affairs and Quality (ORAQ) is hosting a "The Investigational Device Exemption (IDE) Workshop" on March 12 from 9 to 11 a.m.
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
Maryellen Kelly, assistant professor, is the senior author of "Utility Estimation for Neurogenic Bowel Dysfunction in the General Population," which was recently accepted for publication in the Journal of Pediatric Urology. Co-authors include Leah Davis, Kirsten Simmons, a School of Medicine alum, and Jonathan Routh of Duke Health.
The 2021 DUSON Annual Awards Ceremony will be May 5 from 3 to 4 p.m. The event is to celebrate student, faculty and staff excellence. 
Brigit Carter, associate dean for Diversity, Equity and Inclusion, has been invited to serve on the editorial board of 
"Gardening for Health in a Changing World" will occur February 9 at noon. Speakers include educator Kati Henderson and horticulturists Lindsey Luks and Maegan Luckett. Learn how the health of our environment influences human health and how climate change is impacting both. Then, you will be shown how gardening can be used to mitigate those negative effects.
Beth C. Phillips, associate professor, participated in a panel discussion on Professional Identity in Nursing on the Sigma webinar entitled: "
“Exploring Cancer-Related Stigma in Sub-Saharan Africa (ECASSA)” was selected for funding for the interdisciplinary research collaboration pilot grant at the Duke Global Health Institute (DGHI). The PI of the study is Nosa Osazuwa-Peters from the Department of Head and Neck Surgery & Communication Sciences, and Brandon Knettel, assistant professor, will serve as Co-PI.