Aug 9 FDA Grand Rounds highlights impacts of new simulation approaches FDA is using to transform regulatory pathways

What we’re doing to advance in silico medicine at FDA

Register and get CE credit for FDA’s August 9, 2018 Grand Rounds

Thursday, August 9, 2018 12:00 p.m. - 1:00 p.m. EST Register here for webcast (public attendees and FDA staff) CE credit is available Presented by    Tina Morrison, PhD   Deputy Director   Division of Applied Mechanics   FDA’s Center for Devices and Radiological Health What you’ll learn from this FDA mechanical engineer:   1.  What simulation is in the broad range of scientific disciplines   2. What the different approaches are to in silico clinical trials   3. What some of the major FDA success stories are in using simulation approaches.

About the Presentation

FDA advocates for using modeling and simulation as one of many research and product development tools. We routinely advise industry on their use to, e.g.  1) predict clinical outcomes, 2) inform clinical trial designs, 3) support evidence of effectiveness, 4) identify the most relevant patients to study, and 5) predict product safety. In some cases, in silico clinical trials are used to replace human clinical trials, especially those that are intended to evaluate the risk of drug interactions.  FDA is advancing these methodologies and techniques to ensure the benefits of product innovation and more rapidly introduce life-saving technology to our nation’s patients.  

Dr. Tina Morrison, Chair of FDA’s Agency-wide Modeling and Simulation Working group and Regulatory Advisor of Computational Modeling for FDA’s Office of Device Evaluation will give an overview of those methodologies, highlight success stories with simulation, and discuss the potential for in silico clinical trials for advancing medical products.