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Baltimore Marriott Waterfront

Feb 04, 2024 9:00 AM - Feb 04, 2024 4:00 PM

700 Aliceanna Street , Baltimore, MD 21202

Short Course: Aggregate Safety Assessment Planning (ASAP) Process

Instructors

Greg  Ball, PhD

Greg Ball, PhD

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed with statistical and clinical scientists at several pharmaceutical companies. Greg co-leads the PHUSE Safety Analytics working group; he was instrumental in establishing the ASA Biopharm Safety Monitoring working group; and he helped pioneer the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases, University of Chicago, United States

Dr. Barbara Hendrickson is a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is currently on faculty at the University of Chicago. Dr. Hendrickson is a physician with subspecialty training in pediatrics and infectious diseases and has 20 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in multiple new product and additional indication submissions. She also has participated in several clinical trial safety initiatives related to implementation of aggregate safety assessment plans, internal data monitoring committees, and IND aggregate safety reporting procedures. In addition, she co-leads Workstream One of the American Statistical Association's Biopharma Safety Working Group.

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