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Pediatric Cluster Town Hall
Session Chair(s)
Melodi J McNeil, MS, RPh
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development
AbbVie, United States
Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.
Learning Objective : Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.
Speaker(s)
EMA Perspective
Corinne de Vries, PhD, MA, MSc
European Medicines Agency, Netherlands
EMA liaison official to the US FDA
Panelist
Franca Ligas
European Medicines Agency, Netherlands
Scientific Officer, Paediatric Medicines Office
PMDA Perspective
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
FDA Perspective
Dionna Green, MD
FDA, United States
Director, Office of Pediatric Therapeutics
Australia Perspective
Robyn Langham, MD, PhD
Australia Health Products Regulation Group, Australia
Chief Medical Adviser
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