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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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Session 5: CMC Requirements for an IND

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

Part A: Drug Substance

Part A of the IND will discuss in detail how to design the Drug Substance portion of an IND with real examples

Part B: Drug Product

Part B of the IND will discuss in detail how to design the Drug Product portion of an IND with real examples

Part C: Placebo

Part C of the IND will discuss in detail how to design the Placebo portion of an IND in the event placebos are used in clinical trials