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Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
Session Chair(s)
Sarah Walinsky, JD
Director US Regulatory & Policy
Novartis Pharmaceuticals, Corp., United States
This session will explore innovative regulatory approaches, including the ICH E11A guideline, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis.
Learning Objective : Identify innovative regulatory strategies for pediatric drug development, including the ICH E11A guideline; Evaluate the impact of extrapolation and trial design on accelerating access to treatments for children with chronic conditions; Engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.
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