PHUSE Community Forum: Reimagining a Safety Submission – Aggregate Safety Assessment Planning

Greg Ball, of ASAP Process Consulting and Mary Nielson of Eli Lilly present:  Reimagining a Safety Submission – Aggregate Safety Assessment Planning.  The focus of this Community Forum was the various efforts related to interactive safety reviews. The presentation was followed by a discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools.