Development of a Program-Wide Safety Analysis Plan
View Presentation 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.