This year's conference includes presentations from several FDA employees as well as as special FDA Panel Discussion:

FDA Presentations

FDA Panel Discussion

Title: Use of Data and Metadata at FDA: How Has it Changed, Where is it Going?

Abstract: We will be talking with FDA representatives from different parts of the CDER organization about what they do with the material we submit to them. The panel includes those with background in statistical review, medical reviewer, JumpStart, and policy. Three of the panelists will be presenting prior to the panel on related topics.

Time: Wednesday, 10:45 AM - 11:35 AM,   Location: Key Ballroom 9-11


Ron Fitzmartin, Ph.D., MBA
Sr. Advisor, Office of Strategic Programs, CDER / FDA
Eileen Navarro Almario, MD, FACP
Associate Director for Clinical Affairs, CDER / FDA
Alan Shapiro, MD, Ph.D., FAAP
Medical Officer, Office of Computational Sciences, CDER / FDA
Steve Wilson, Dr.P.H., CAPT USPHS
Director, Division of Biometrics III, FDA/OMPT/CDER/OTS/OB
Weiya Zhang, Ph.D.
Statistical Reviewer, Division of Biometrics III, FDA/OMPT/CDER/OTS/OB
Sandra Minjoe
Senior ADaM Consultant, Accenture Accelerated R&D Services