ADaM Review from a CDER Statistical Reviewer's Perspective
View Presentation *Behrang Vali, FDA/CDER/OTS/OB/DBIII Keywords: The U.S. Food and Drug Administration and CDISC are currently working together to develop standards for NDA/BLA analysis data submissions. This session will provide the audience with insights into the regulatory review of NDA/BLA analysis data with an emphasis on reviewing analysis data modeled utilizing CDISC/ADaM. The session will discuss what regulatory reviewers are currently learning about analysis files based on ADaM implementation while also discussing reviewers’ likes and dislikes regarding the model.
|
Key Dates
-
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