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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

CDISC SHARE: A Promising Approach to Therapeutic Area Standards Development

Session Chair(s)

Wayne R. Kubick, MBA

Wayne R. Kubick, MBA

Chief Technology Officer

HL7 International, United States

This session provides an orientation to the thinking behind the CDISC SHARE project metadata library and how this method can support computable semantic interoperability (CSI), regulatory requirements and therapeutic area standards development.

Learning Objective : Discuss the benefits of a metadata approach to standards development; Describe the methodology being used in therapeutic area standards development and the tools being used; Explain how therapeutic area developments will impact your organization.

Speaker(s)

Wayne R. Kubick, MBA

Information Requirements for Data Standards

Wayne R. Kubick, MBA

HL7 International, United States

Chief Technology Officer

Diane E. Wold, PhD

The New Model-based Standards Development Process

Diane E. Wold, PhD

CDISC, United States

Director, Concept Modeling

David Peter Iberson-Hurst

Practical Electronic Data Standards From the New Process

David Peter Iberson-Hurst

Assero, United Kingdom

CEO

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