Health Science Policy Analyst
FDA
Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving decentralized clinical trials, digital health technologies and electronic records and storage in clinical investigations (Part 11). She worked for 15 years in the Center for Devices and Radiological Health (CDRH) in guidance document development and as a branch chief overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.
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FDA Expectations for using Digital Tools in Decentralized Clinical Trials
Wednesday, October 4, 2023
2:00 PM – 3:00 PM EDT