| Reimagining a Safety Submission – Aggregate Safety Assessment Planning |
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Hear from PHUSE Safety Analytics Working Group Leads Mary Nilsson and Greg Ball, as well as Barbara Hendrickson and Robert Gordon, as they introduce two new FDA premarket safety analytics documents. A discussion will then take place on how past and current efforts from cross-industry Working Groups can be leveraged to prepare the ecosystem for operationalising them. Welcome Aggregate Safety Assessment Planning – Some Thoughts on the Vision PHUSE Analysis and Displays White Papers PHUSE AE Groupings in Safety (AEGiS) Project Team DIA-ASA Interdisciplinary Safety Evaluation (DAISE) Working Group: The Aggregate Safety Assessment Planning (ASAP) Project Team Discussion |