TL56: Program Safety Analysis Plan and Safety Reporting Rules
*Wei Wang, Eli Lilly And Company Keywords: Program Safety Analysis Plan, SPERT, Safety, meta-analysis Better planning and implementation of meta-analysis of safety data early in drug development is becoming increasingly important. This round table discussion will provide an opportunity to share insights, experiences and perspective regarding implementation of a program safety analysis plan (PSAP) as recommended by Safety Planning, Evaluation and Reporting Team (SPERT). There are 3 key questions to be addressed during the discussion. 1) Has your company implemented the SPERT recommendation to create Program Safety Analysis Plans (PSAPs)? If so, how is it implemented in your company, and has it added value? If not, is implementation in your future plans? *SPERT- Safety Planning, Evaluation and Reporting Team 2) What are the challenges you have experienced/anticipate in the implementation of PSAPs in your company? 3) How can we best encourage the use of PSAPs as a safety planning tool?
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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