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Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
Session Chair(s)
Christina Bucci-Rechtweg, MD
Global Head, Maternal Health and Pediatric Regulatory Policy
Novartis , 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; Recognize ways to engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.
Speaker(s)
Panelist
Laura Jawidzik, MD
FDA, United States
Division Director, OND. CDER
Panelist
Lauren Krupp, MD
NYU Langone Health, United States
Director, Multiple Sclerosis Comprehensive Care Center
Panelist
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
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