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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

返回 Agenda

Welcome, Introduction, and Session 1: Introduction/Overview of FDA

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

  • FDA’s mission and how FDA is organized
  • CDER/CBER/CDRH role and responsibility
  • Critical role of FDA reviewer
  • Role of FDA chemistry reviewer
  • Responsibility of sponsor
  • What is CM&C
  • FDAs concerns with CM&C
  • Laws, regulations, policies and procedures

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