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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, Standards and Development, CDISC
Rhonda Facile has +25 yrs of clin research experience including monitoring, project management, outsourcing, planning and regulatory affairs. At CDISC she is CFAST Program Manager, a project that seeks to develop Therapeutic Area data standards.

Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Advisor, Office of Strategic Programs, CDER, FDA
Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at Daiichi Medical Research, and Exec Dir, Biostatistics and Data Management at Purdue Pharma L.P. Ron was elected President of the DIA 07-09. Ron received a PhD in... 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 for statistics.
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 to the CDISC Therapeutic Area Standards program.

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