Latest Past Events

Overall Safety Assessment – Interactive Safety Graphics for Regulatory Decision-Making

Jeremy Wildfire, Sr. Director of Biostatistics, Gilead, Steve Mallett, Sr. Manager of Statistics, Veramed & Mat Soukup,  Deputy Division Director and Office Biostatistics representative, FDA/CDER join Greg Ball, ASAP Process Consulting, to discuss interactive safety graphics:  industry's exploration and nascent use, value comparison to traditional static graphics, and exploration of use of interactive safety graphics in submissions...

Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest

In this part 3 of PHUSE's 5 part webinar series on Interdisciplinary Safety Evaluation for Learning and Decision-Making, Greg Ball of ASAP Process Consulting joins Mac Gordon, Director of Statistics, Johnson & Johnson, Peg Fletcher, Safety Physician and CEO of MedAssessment, and Scott Proestel, Sr. Medical Officer, FDA to discuss FDA Medical Queries and AE Groupings for...