A Safety Surveillance Plan (SSP) for Serious Anticipated Events

A number of questions remain about Safety Surveillance Plans (SSPs). This session, Chaired by Greg Ball of ASAP Process Consulting, presents experiences from  multiple sponsors who have developed processes to address the FDA’s recommendations in the 2021 guidance.  Topics such as:  identifying when a safety surveillance plan (SSP) is warranted; specifics on implementation of the trigger method; how to evaluate a product in different patient populations and ensure study integrity;  clarification of roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting, and more.