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?
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC