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DIA Global Center

11 sep 2017 8:15 a.m. - 12 sep 2017 3:30 p.m.

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

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

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Sessions 25 and 26

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

Session 25: Beyond Approval – Post Approval Changes

This section will drill down into the realm of post approval changes such as PAS's, CBE's, and ARs
SUPAC documents will be discussed which are integral in the post approval world

Session 26: Changes Reportable in an Annual Reports

Components and Composition
Manufacturing Sites and Process
Specifications
Container/Closure System

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