Coaxing ADaM data into formats useful for review by both clinical and statistical reviewers
View Presentation *Joy Mele, FDA/CDER/OTS/OB/DBIII Keywords: ADaM datasets offer a predictable standard for analysis data but not all data fits easily into this model. In addition, the model may not provide data in a format that helps reviewers answer regulatory questions. With examples, this talk will illustrate how the ADaM structure is helpful to reviewers and describe improvements that may be needed to promote the advantages of using ADaM datasets for the review of NDA/BLA data.
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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