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Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle
Session Chair(s)
Claudia Ana Ianos, MD
Senior Director, Safety Risk Management Lead
Pfizer, United States
Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.
Learning Objective : Demonstrate the need for a continuous approach to benefit-risk planning; Recognize the risks of failing to conduct benefit-risk planning; Identify ways to introduce benefit-risk planning into drug development
Speaker(s)
Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Robyn Bent, BSN, MS, RN
FDA, United States
Director, Patient Focused Drug Development, OCD, CDER
Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Diana Morgenstern, MD, FACP
Viatris, United States
Head, Real World Evidence and Outcomes Research
Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Megan Aragon, MBA
East Texas Lighthouse for the Blind, United States
Technology Services Administrator
Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Bennett Levitan, MD
Johnson & Johnson, United States
Executive Director, Benefit-Risk Assessment / Epidemiology
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