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There is now a CONTENT FREEZE for Mercury while we switch to a new platform. It began on Friday, March 10 at 6pm and will end on Wednesday, March 15 at noon. No new content can be created during this time, but all material in the system as of the beginning of the freeze will be migrated to the new platform, including users and groups. Functionally the new site is identical to the old one. webteam@gatech.edu
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Kelly Lindblom, Ph.D., R.A.C.
Regulatory Affairs Scientist
Duke University School of Medicine
This workshop will offer best practices when conducting trials using FDA approved and unapproved devices. It will give an overview of the marketing process for medical devices, the IDE application process, and the obligations of the sponsor-investigator once the IDE application 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):
This course is designed for anyone directly involved in conducting investigator-initiated trials:
Kelly Lindblom, Ph.D., is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Lindblom is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Lindblom is also involved in the implementation of educational initiatives within ORAQ.
Lindblom received her undergraduate degree in chemistry from the University of North Carolina-Chapel Hill. She conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. Her research focused on the regulation of cell death in the context of Non-Alcoholic Steatohepatitis and different types of cancer. During her graduate training, Lindblom was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. Lindblom was the Assistant Director of Research Initiatives in the Office of the Vice Provost for Research at Duke University before joining ORAQ.
