Development of a Program-Wide Safety Analysis Plan
View Presentation Qi Jiang, Amgen Seta Shahin, Amgen, Inc. *Amy Xia, Amgen, Inc. Keywords: Program Safety Analysis Plan, SPERT, Drug Safety Assessment Proactive planning of safety evaluation throughout a product’s lifecycle is an essential part of drug development. Recommendations for the evaluation of safety information during product development have recently emerged. As a result, a program safety analysis plan (PSAP) has been proposed as an industry standard by the PhRMA Safety Planning, Evaluation and Reporting Team (SPERT). We will discuss the timing and framework of the PSAP as well as the principles for safety data collection and analyses. We will share our initial experience in developing the PSAP intended to advance the way clinical trial safety data are prospectively collected, analyzed and presented.
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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