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?