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Kelly Winn, MS

Contact Details

United States

Bio

Kelly Winn, MS, CIP, RAC, Director of Human Research Protection Program and Regulatory Affairs, BS from Kennesaw State University, Major Biology, MS from University of Georgia, College of Pharmacy, Kelly Winn first came to the Georgia Institute of Technology in 2001 working as a veterinary technician in the PRL. She worked as a veterinary technician for GT until 2004 when she decided to make the transition from pre-clinical research into clinical research by working for a commercial IRB in Atlanta for four years. Kelly came back to Georgia Tech’s Office of Research Integrity Assurance as an IRB compliance officer in 2008 as a founder and manager of the GSU/GT Joint Center for Advanced Brain Imaging IRB and participating member of the GT Central IRB. She applied the knowledge she gained from working with industry into the academic clinical research performed at GT. Ms. Winn obtained her globally recognized CIP (developed by the Council for Certification of IRB Professionals (CCIP)) certification in 2010 and remains a current holder. In 2014-2015, Ms. Winn obtained her MS with an emphasis in Regulatory Affairs from the University of Georgia’s College of Pharmacy while working full time at GT as an IRB compliance officer in the Office of Research Integrity Assurance. During this time, she also completed the University of Georgia’s BioPharma Regulatory Affairs Certificate Program. The University of Georgia's Bio Pharma Regulatory Affairs Program addresses the fundamental regulatory needs for the following types of FDA-regulated products: • Pharmaceuticals • Biologics • Medical Devices and IVDs • Veterinary Products • Combination Products • International Regulations In 2016, Ms. Winn was named Associate Director for the first Regulatory Affairs department at Georgia Tech and then transitioned into being named Director of the Human Subjects Research Protection Program (HRPP) and Regulatory Affairs in 2017. Including management of two departments within ORIA (IRB and Regulatory), Ms. Winn’s role is to provide leadership and professional regulatory and compliance oversight for Georgia Tech’s growing portfolio of biomedical research that is subject to the Federal Food, Drug and Cosmetic Act. These projects include healthcare products: medical devices, in-vitro diagnostics, biotechnology/nanotechnology, pharmaceuticals, and biologics. She provides guidance and consulting for 510(k) prep, PMA prep, Design Controls, Quality Systems, IND and IDE prep and regulatory oversight for research and development, pre-clinical and clinical Phase I/II trials. She provides training and lectures on regulatory issues among the different departments throughout the campus of the Georgia Institute of Technology Institute.
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Education

  • Master’s degree

Regional Areas of interest

  • Europe
  • Global
  • North America