Back to Agenda
Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning
Session Chair(s)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States
This session discusses the work of the Drug Information Association - American Statistical Association Aggregate Safety Assessment Plan (ASAP) and Benefit Risk Assessment Planning (BRAP) task forces. The ASAP promotes a systematic approach to safety planning and evaluation via collaboration of statisticians, epidemiologists, clinicians and other functional experts. The BRAP task force is working to improve collaboration and communications between disciplines within an organization and with regulatory agencies regarding benefit-risk assessments.
Learning Objective : Describe a model of multidisciplinary collaboration for program-level safety assessment and benefit-risk planning; Cite key aspects of safety planning to consider at various product lifecycle stages including determining reference event rates; Recognize the benefits of proactive safety planning and ongoing aggregate safety evaluations; Discuss ways to enhance communication and collaboration between disciplines and with regulatory agencies regarding benefit-risk assessments.
Speaker(s)
Aggregate Safety Assessment in Ongoing Studies
Greg Ball, PhD
ASAPprocess, United States
Safety Data Scientist
Benefit-Risk Assessment Planning
Lisa Rodriguez, PhD
FDA, United States
Deputy Division Director, OB, OTS, CDER
Survey of Benefit Risk Assessment Planning Practices
Michael Colopy, PhD, MPH
UCB Biosciences, United States
Safety Statistics and Decision Scientist
Role of Epidemiology in Aggregate Safety Assessments
Susan Colilla, PhD, MPH
Teva Pharmaceuticals, United States
Epidemiology Leader
Have an account?