Operationalizing FDA Medical Queries

Chaired by Greg Ball of ASAP Process Consulting and PHUSE AE Groupings in Safety (AEGiS) Project Team, this session introduces new FDA guidance focused on enhancing safety analytics and discuss how cross-industry working groups have been preparing the ecosystem for operationalizing them: FDA Medical Queries and Standard Safety Tables and Figures.  In addition to Robert Robert (Mac) Gordon, J&J and PHUSE Safety Analytics Working Group, and Barbara Hendrickson, MD, Safety Physician and DIA-ASA Interdisciplinary Safety Evaluation (DAISE) Working Group: The Aggregate Safety Assessment Planning (ASAP) Project Team, FDA speakers include: Scott Proestel, MD,  Y. Veronica Pei, MD, MEd, MPH.