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DIA Global Center

11 sep 2017 8:15 a.m. - 12 sep 2017 3:30 p.m.

21 Dupont Circle NW, Suite 300, Washington, DC 20036

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

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Session 27: CMC Considerations in Pediatric Development

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., 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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