TL42: Revisiting PSAPs: Sharing experience, How it's evolving
*Susan P Duke, GSK 

Keywords: PSAP, SPERT, Safety analysis

The purpose of this roundtable is to share experience so that we may improve patient safety by sharing success stories and how use of Program Safety Analysis Plans is evolving several years after the SPERT recommendations were published (Crowe, et al, 2009).

Questions for discussion: 1. Have you implemented a PSAP (or PSAP process), and what have been your experiences? 2. Have you had any experience with the PSAP and regulatory interactions (End of phase 2, submission)? 3. What methodologies are people using for safety signal detection and characterization? 4. Have you used extreme value modeling or Bayesian methods? 5. Have you used safety graphics? 6. Have you found any roadblocks to implementing PSAPs? 7. What areas in safety analysis of clinical trial data have you found most challenging?