Presenter

QuynhNhu Nguyen is the Director, Human Factors and Regulatory Strategy at Kymanox and has over 15 years of FDA regulatory science and evaluation experience with human factors, medication errors, product design and development. She has 11+ years of professional experience leading and managing scientific and regulatory evaluation of all human factors submissions related to combination products including 5+ years with Center for Drug Evaluation and Research (CDER)’s Division of Medication Error Prevention and Analysis (DMEPA), and 6+ years with Center for Devices and Radiological Health’s Human Factors Premarket Evaluation Team (HFPMET).

QuynhNhu led CDRH’s human factors reviews on 444 medical products that have both device and drug/biologic constituents (also known as combination products) and on 244 Human Factors/device usability expertise consultative reviews for a variety of premarket submissions received in CDRH. She co-led the development of human factors program in DMEPA CDER from conception to current state by ensuring adequate staff, resources, and tools to perform CDER regulatory reviews of human factors submissions. She ensured consistent human factors evaluations taking into considerations scientific and regulatory landscape cross 500+ products that cover all therapeutic areas beginning from investigational product development phases to
marketing applications to post market extension phases.

QuynhNhu is a highly sought-after FDA/CDER human factors speaker with 20+ presentations at professional conferences and training. She has led or co-led 6 publications focusing on medical device engineering as well as human factors engineering and participated as a subject matter expert and advisor in 3 broad agency announcements and research related to human factors. She has a keen knowledge and understanding of the intersection between product design and development, human factors, and medication use process to identify approaches to minimize and prevent use errors as well as medication errors.

QuynhNhu earned a Master of Science Degree in Systems Engineering from Johns Hopkins University as well as a bachelor’s degree in Biomedical Engineering from George Washington University.