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Tuesday, June 28 • 2:00pm - 3:15pm
#240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards

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Limited Capacity seats available
Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

This CFAST session will focus on some of the innovative approaches being used to move towards E2E concept-based standards development and show the value these enhanced standards can bring for all stakeholders involved. Analysis elements (ADaM) and therapeutic area user guides (TAUGs) will also be discussed as well the therapeutic area (TA) Specification project which seeks to include TA metadata into the FDA standards catalogue.

Learning Objectives

Recognize the CFAST Initiative and the potential benefit of implementing these standards; Discuss some of the innovative approaches employed to move closer to E2E concept based data standards; Recall the FDA Therapeutic Area User Guide Specification project.

Chair

Rhonda Facile, MS

Speaker

CFAST Program Participation and the FDA Specification Project
Ron D. Fitzmartin, PhD, MBA

ADaM and Therapeutic Area User Guides: Current Thinking
Susan J. Kenny, PhD

Biomedical Concepts and End-to-End Metadata Development
Diane E. Wold, PhD


Chair
avatar for Rhonda Facile

Rhonda Facile

Vice President, Development Opportunities, CDISC
Rhonda Facile has over 25 years of clinical operations experience. She has worked in a global CRO, pharmaceutical and biotechnology companies both in the United States and abroad. She has experience in clinical trial monitoring, project management, regulatory affairs and standards... Read More →

Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Data Standards Staff, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Susan Kenny

Susan Kenny

President, Maximum Likelihood, Inc.
Susan is a biostatistician with 20 years of experience in research for public health and for the pharmaceutical industry. She has been active in CDISC since 2000 and is a senior team member of ADaM. Her areas of interest included CDISC implmentation strategies and graphical methods... Read More →
avatar for Diane Wold

Diane Wold

Director, Concept Modeling, CDISC
Diane Wold received her PhD in Statistics from UNC-Chapel Hill. She joined Burroughs Wellcome in 1984 as a project statistician held a variety of positions, leading to her current role in Data Standards at GSK. Since 2002, she has been active in CDISC, and currently provides consultation... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session