Some Thoughts on Benefit:Risk Assessment
View Presentation *Qi Jiang, Amgen Inc. Chunlei Ke, Amgen Inc. Laura Bloss, Amgen Inc. Elias Kouchakji, Amgen Inc. Steven Snapinn, Amgen Inc. Jose Vega, Amgen Inc. Keywords: Benefit:Risk, Quantitative Evaluation, Subgroup There have been many different approaches proposed for the quantitative evaluation of the benefit:risk of a biopharmaceutical product. In this presentation we will discuss various benefit:risk assessment approaches that can be potentially used to meet the needs of global regulatory agencies, health technology assessment organizations and prescribers. Some of the challenges we will address include criteria for comparison of benefit:risk approaches, selection of weights and patient preference, and identification of a subgroup with an enhanced benefit:risk profile.
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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