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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 Inc, United States
Benefit-risk planning is recommended by both FDA and CIOMS XII but is often neglected in practice. In this forum, a panel will discuss the risks of failing to conduct 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
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