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DIA 2018 Global Annual Meeting

Evolving CDISC Standards and Technologies  

    Session Chair(s)
      Rhonda  Facile, MS

      Rhonda Facile, MS

      • Vice President, Standards and Development
      • CDISC, United States
    This session will include the latest updates on CDISC standards with examples and annotated case report forms or survey instruments to improve semantic understanding, support data sharing, and facilitate global regulatory submission. 
    Learning Objective : Discuss the PDUFA VI and how this regulation relates to the use of data standards; Identifyl how CDISC is responding to PDUFA VI; Explain how FDA is preparing for the upcoming mandate to use LOINC; Describe the therapeuitc area standards program and the role of global regulatory authorities in their development and endorsement.
      Kit  Howard, MS

      CDASH and SDTM: Why You Need Both

      Kit Howard, MS

      • Director of Education
      • CDISC, United States
      Lauren  Becnel

      SHARE Metadata Repository

      Lauren Becnel

      • Vice President, Strategy and Innovation
      • CDISC, United States