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TL54: Safety Evaluation: When, What, How?
*Aloka G Chakravarty, US FDA Keywords: safety, meta-analysis, best practices This roundtable will talk about strategies for quantitative safety evaluation of drugs and therapeutic biologics. Issues and best practices related to focused safety evaluation will be discussed. Pre-planning for safety evaluation, considerations for a complete data submission, early discussion with the FDA and meta-analytic considerations will be discussed, along with case examples.
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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
