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Progress in Pediatric Therapeutics
Session Chair(s)
Ronald Portman, MD
Executive Director, Pediatric Development, Science and Innovation
Clinical Development & Analytics, Novartis Pharmaceuticals Corporation, United States
The availability of safe, effective therapies is critical to meet the needs of pediatric patients. FDA’s 2016 status report on the BPCA and PREA concluded that progress has been made in obtaining pediatric studies and new labeling but significant challenges remain in studies for neonate, infants, pediatric cancer, and international coordination of pediatric trials.
This DIAmond panel will discuss recent progress in global pediatric research and regulatory science and new developments in pediatric research networks such as the Pediatric Trials Consortium (C-Path Institute) and the International Neonatal Consortium.
Learning Objective : Discuss recent legislative and regulatory developments in the US and EU related to pediatric studies and labeling and their expected impact on availability of safe and effective therapies for children; Identify regulatory and research approaches to address challenges that limit the availability of innovative medicines for infants, neonates, and children.
Speaker(s)
Panelist
Susan McCune, MD
PPD, United States
Vice President, Pediatrics and Clinical Pharmacology
Panelist
Mark Turner, MD, PHD, MRCP, FFPM
University of Liverpool, United Kingdom
Chief Executive Officer of the c4c- Stichting (c4c-S) & Professor of Neonatology
Panelist
Robert M. Ward, MD
University of Utah, United States
Professor Emeritus of Pediatrics, Neonatology, Clinical Pharmacology
Panelist
Christoph Male, MD
Medical University of Vienna, Austria
Associate Professor of Paediatrics
Panelist
Marie-Helene Pinheiro, PHARMD
European Medicines Agency, Netherlands
Industry Stakeholder Liaison, Corporate Stakeholders Department