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DIA Global Center

2017 年 09 月 11 日 8:15 上午 - 2017 年 09 月 12 日 3:30 下午

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

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

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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