RL07 Path from SDTM to ADaM for Regulatory Submission
*Sun Sook Kim, BioMarin, Inc Keywords: The success of the CDISC pilot program of the SDTM (Standard Data Tabulation Model)/ADaM (Analysis Dataset Model) with FDA set expectations that pharmaceutical/biotech industry sponsors will provide submission data in SDTM- and ADaM-compliant formats in the very near future. BioMarin Pharmaceutical Inc. successfully submitted the Kuvan NDA last year in SDTM format, and we are gearing towards preparing all submission datasets in SDTM- and ADaM-compliant formats. In this open forum, I’d like to share BioMarin’s approach to accomplishing this mission, and give others the opportunity to share their approaches to submitting data in these formats.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC