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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.

Chair

Mary Ann Slack

Speaker

OCP Update
Eileen E. Navarro Almario

CDER Perspective
Colleen Ratliffe, MS, PMP

FDA Update
Stephen E. Wilson, DrPH



Chair
avatar for Mary Ann Slack

Mary Ann Slack

Deputy Director, Office of Strategic Programs, CDER, FDA
Ms. Slack has over 30 years’ technology and informatics experience implementing informatics solutions to business problems. Since joining FDA in 2003, she has been engaged in data standards development efforts in CDISC, HL7 and ISO in support of Agency needs. Ms. Slack is an FDA representative to the International Conference on Harmonization (ICH) and currently serves as Deputy Director for CDER's Office of Strategic Programs and leads CDER's... Read More →

Speakers
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 College of Physicians and is board certified in Infectious Diseases. She has contributed to drug development guidances, therapeutic area standards development, PRO... 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 guidance that focus on data standards. She leads and is responsible for multiple projects and is also the FDA liaison for study data related activities with the... 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
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA