Associate Director of Regulatory Affairs
Office of Regulatory Affairs and Quality
Duke University School of Medicine
Erika Segear, PhD, RAC is the Associate Director of Regulatory Affairs in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Segear works with a team of Regulatory Affairs professionals who serve as a no cost resource to the clinical research community at Duke University. She is responsible for providing guidance and support to Duke investigators in various aspects of regulatory affairs, including regulatory strategy development, preclinical testing, product manufacturing, FDA meetings, regulatory submissions, and regulatory education. Dr. Segear also co-leads Duke’s Expanded Access Committee and led the development of a resource that assists physicians at Duke University in obtaining regulatory approvals for use of investigational drugs under FDA’s Expanded Access program. Finally, she oversees and manages implementation of new educational, operational, and collaborative initiatives within ORAQ. Prior to joining ORAQ, Dr. Segear conducted her graduate research studies at Duke, where she earned a PhD in Molecular Cancer Biology with a certificate in Cell and Molecular Biology. During her graduate training, she was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award.
Saturday, November 17
11:30 AM – 12:45 PM