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Evolving CDISC Standards and Technologies
Session Chair(s)
Rhonda Facile, MS
Vice President, Partnerships 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; Identify how CDISC is responding to PDUFA VI; Explain how FDA is preparing for the upcoming mandate to use LOINC; Describe the therapeutic area standards program and the role of global regulatory authorities in their development and endorsement.
Speaker(s)
CDASH and SDTM: Why You Need Both
Kit Howard, MS
CDISC, United States
Senior Director, Standards Development & Education
SHARE Metadata Repository
Bess LeRoy, MPH
CDISC, United States
Head of Standards Development