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Tuesday, June 28 • 4:00pm - 5:15pm
#264: FDA Update on Data Standards

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-538-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include information on required data standards in regulatory submission and FDA's efforts to develop, test, and support therapeutic area data standards. Discussion will include FDA's participation in and status of international data standards initiatives such as IDMP.

Learning Objectives

Discuss required data standards in NDAs, BLAs, INDs and ANDAs 2; Summarize FDA's efforts to develop, test and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives, such as IDMP.


Mary Ann Slack


OCP Update
Eileen E. Navarro Almario

CDER Perspective
Colleen Ratliffe, MS, PMP

FDA Update
Stephen E. Wilson, DrPH

avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Colleen Ratliffe

Colleen Ratliffe

Project Management Officer, Office of Strategic Programs, CDER, FDA
Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy and... Read More →
avatar for Stephen Wilson

Stephen Wilson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA/CDER for 28 years and is currently the Director of the Division of Biometrics III and a Captain in the USPHS. He received his doctorate in Biostatistics from UNC/Chapel Hill in 1984.

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session