CMC Workshop 2015

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Session 06B: Pediatrics

Session Chair(s)

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