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Pediatric Drug Development
Session Chair(s)
Maureen Smith, MEd
Member
Clinical Trials Ontario College of Lived Experience, Canada
There is greater demand from regulatory and clinical care communities to include pediatric patients in clinical development. However, inclusion of pediatric patients poses unique challenges in preclinical work, clinical trials, and navigation of regulatory processes. The aim of this panel is to describe the challenges and to offer approaches and solutions to help overcome them. We will discuss animal models and drug screening platforms, clinical trial design, unique information needs, and regulatory pathways. Attention will be given to highlighting differences in pediatric orphan drug development and regulatory frameworks in major and emerging geographies.
Learning Objective : Discuss the unique development and regulatory challenges of developing drugs in pediatric rare disease patients; Describe approaches and solutions to overcome these challenges.
Speaker(s)
Preclinical and Clinical Drug Development in Juvenile Rare Diseases
Shu-Wha Lin
National Taiwan University College of Medicine , Taiwan
Professor, Department of Laboratory Science Medical Biotechnology
Regulatory Framework in Pediatric Rare Diseases
Dinah Duarte, MSc
European Medicines Agency, Netherlands
Signal Management Lead