DIA 48th Annual Meeting
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NDA/BLA Statistical Review and the CDISC ADaM Data Standards
Track
:
Track 15: Statistical Science and Quantitative Thinking
Program Code:
214
Date:
Tuesday, June 26, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Stephen Wilson, FDA, United States
PRESENTER
(S):
Behrang Vali, FDA, United States James Johnson, UCB BioSciences Inc., United States
Michael Nessly, Shire Specialty Pharmaceuticals, United States
Description
This forum will describe the receipt and statistical review of analysis files based on the ADaM standards at the Center for Drug Evaluation and Research. The panel will discuss problems and potential improvements
Learning Objectives:
Describe the experience with the receipt and review of ADaM-based analysis files by CDER statisticians
Identify areas of improvement for ADaM standards and review processes and tools.
Learning Objectives:
Describe the experience with the receipt and review of ADaM-based analysis files by CDER statisticians
Identify areas of improvement for ADaM standards and review processes and tools.
This session is a part of:
Handout Online
