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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