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DIA Global Center

Sep 11, 2017 8:15 AM - Sep 12, 2017 3:30 PM

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

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

Back to Agenda

Sessions 18, 19, and 20

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

Session 18 : The NDA Labels

The NDA Labels
Immediate Container Label
Carton Label

Session 19: The Global Development Plan

Components of a Global Development Plan
Manufacturing Strategy (CMC Development Plan)
Risks and Issues

Session 20: Preparing for CMC Meetings with FDA

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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