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DIA Global Center

15 oct 2018 8:15 a.m. - 16 oct 2018 3:30 p.m.

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

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

Session 25: Beyond Approval - Post-Approval Changes

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

  • 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

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