Greg Ball represented PHUSE's Safety Analytics Working Group at the PHUSE/FDA Computational Science Symposium (CSS) 2024, along with Scott Proestel, Sr. Medical Officer, FDA, and Mary Nilsson, Statistician, Eli Lilly.  CSS brought together a community of 212 passionate individuals. who gained access to direct insights into regulatory topics from health authorities and explored a range...

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...