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DIA Global Center

Oct 15, 2018 8:15 AM - Oct 16, 2018 3:30 PM

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

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

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Session 20: Preparing for CMC Meetings with FDA

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

Strategies for Meeting with FDA
Planning and Important Documents for a CM&C Meeting
Meeting Request Letter
The Briefing Document
Regulatory Mechanism for an FDA Meeting
Preparing for the Meeting, Rehearsals; During the Meeting
Types of Meetings Encountered During Drug Development

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