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Wednesday, June 27 • 4:00pm - 5:15pm
#387: Evolving CDISC Standards and Technologies  

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-678-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Rhonda Facile, MS

Speaker

CDASH and SDTM: Why You Need Both
Kit Howard, MS

SHARE Metadata Repository
Bess LeRoy, MPH


Speakers
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 →
avatar for Kit Howard

Kit Howard

Senior Director, Standards Development & Education, CDISC
Kit Howard has over 30 years’ experience in many areas of research and development, including developing data and process standards for exploratory through post-marketing human clinical research, pharmacogenomics and non-clinical research. She is CDISC's Senior Education Expert... Read More →
BL

Bess LeRoy

Head of Standards Development, CDISC
Bess LeRoy has over 15 years of experience working in public health research. She is currently the Head of Standards Development at CDISC. She has been a CDISC team member since 2011 and has been involved in the development of over 16 CDISC Therapeutic Area User Guides. Bess has a... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Session