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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

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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