Back to Agendas
The State of Pediatric Research in the United States
Session Chair(s)
Chin Koerner, MS
Executive Director, Development and Regulatory Policy, Novartis , United States
Pediatric research in the US has been evolving for the past 20 years. With the 2012 passage of permanant legislation to support pediatric research we are at the dawn of a new age to enable the availability of medicines for children.
Learning Objective : Define the US legal and regulatory framework for mandatory and voluntary pediatric studies; Discuss the efforts to build an infrastructure to enable such reseach to be conducted; Identify collaborative efforts being made by stakeholders to ensure future success of pediatric research efforts.
Speaker(s)
The Best Pharmaceuticals for Children Act: FDA/NIH Collaboration to Increase Pediatric Information in Product Labeling
Donna Snyder, MD
Executive Physician, WCG, United States
FDA Perspective
Rosemary M. Addy, MHS
Supervisory Consumer Safety Officer, Office of New Drugs, CDER, FDA, United States
Industry Perspective
Ronald Portman, MD
Executive Director, Pediatric Development, Science and Innovation, Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, United States
Have an account?