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Session 06B: Pediatrics
Session Chair(s)
Dr. Peter Richardson, PHD
Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency, Netherlands
This session will look at some of the issues arising during development of pediatric formulations; covering industry experiences and reflecting on the regulatory requirements in both the USA and EU. Progress continues to be made in this area and EMA has recently reviewed guidance at a workshop with industry. Outcomes from the workshop and how these may facilitate further evolution of this topic will be considered by speakers from both industry and regulatory authorities.
Speaker(s)
Challenges Associated with Developing Medicines for Children: An Industry Perspective
Gossett Campbell
GlaxoSmithKline, United States
Sr. Scientific Investigator, CMC Technical Leader Global Formulation Development
Navigating the Pediatric Formulation Landscape: “Considerations for a Successful Global Journey” <i>This presentation will be given via WebEx</i>
Robert Ternik, PHD
Eli Lilly and Company, US, United States
Senior Research Advisor
Pediatric Medicines - EU Regulatory Perspective
Piotr Kozarewicz
European Medicines Agency, Netherlands
Scientific Administrator