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

This interactive virtual training course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

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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