SESSION KEYNOTE

Keynote 3: New Statistical Initiatives in the FDA CDRH
Speaker: Ram Tiwari, CDRH, FDA
Moderator:
Bill Wang

Abstract:

In this keynote, I will present some innovative Frequentist/Bayesian statistical methods that supports the CDRH mission for development of first of its kind in the world, safe, and effective medical devices. These methods include: i) leveraging information from a real-world data (RWD) source to construct or augment the control arm or a single-arm in an investigational clinical study, ii) benefit-risk assessment for a therapeutic or a diagnostics device, iii) likelihood-ratio-test (LRT) based signal detection methods for large safety databases, and iv) a site-selection tool for inspection.

Instructor’s Bio:

Ram C. Tiwari, Ph.D. is the Director for Division of Biostatistics, CDRH, effective June 27, 2016. He joined FDA in April 2008 as Associate Director for Statistical Science and Policy in the Immediate Office, Office of Biostatistics, Office of Translational Sciences, CDER. Prior to joining FDA, he served as Program Director and Mathematical Statistician in the Division of Cancer Control and Population Sciences at National Cancer Institute, NIH; and as Professor and Chair, Department of Mathematics, University of North Carolina at Charlotte.

Dr. Tiwari received his MS and PhD degrees from Florida State University in Mathematical Statistics. He is a Fellow of the American Statistical Association and a past President of the International Indian Statistical Association. He has published 200+ research papers on a wide range of statistical topics. His current research interests include developing frequentist and Bayesian methods in clinical trials and pre-and-post market drug/device safety evaluation.

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