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Virtual Training Course (US Eastern Time)

Jul 13, 2020 9:00 AM - Jul 16, 2020 2:00 PM

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

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Session 23: CMC Considerations in Pediatric Development

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

Pediatric Regulatory Considerations
The Best Pharmaceuticals for Children’s Act (BPCA)
Pediatric Research Equity Act (PREA)
FDA – Pediatric Study Plans
Introduction
Contents of a PSP
Pediatric Formulations Development

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