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Keynote

Speaker

Tina Morrison, Ph.D.,  Deputy Director, Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Title

Priorities Advancing Regulatory Science and In Silico Medicine at the FDA



Biography

Tina Morrison is the chair of the new FDA-wide working group on Modeling and Simulation, sponsored by the Office of the Chief Scientist, which launched in 2017.  She has been serving as the Regulatory Advisor of Computational Modeling for the Center for Devices and Radiological Health (CDRH) since 2012.  In that capacity, she leads the Regulatory Review of Computational Modeling working group, which has developed guidance documents on the use of modeling and simulation in the regulatory evaluation of medical devices [1].  She dedicates much of her energy towards advancing regulatory science through modeling and simulation because she believes the future of medical device design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization [2].  

She serves as Chair of the ASME V&V Standards Committee on Verification and Validation of Computational Modeling, the Subcommittee V&V40 on Computational Modeling of Medical Devices, where she is leading the development of a strategy to assess the credibility of computational models [3].  She is also working with a team at CDRH to implement this strategy into the review of premarket submissions that leverage computational modeling [4].  For seven years, she was a scientific reviewer on a variety of medical device premarket submissions in Cardiovascular Devices.  She is the Deputy Director of the Division of Applied Mechanics in FDA’s Office of Science and Engineering Laboratories.  She is a mechanical engineer who received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.