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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 12, 13, 14, 15, and 16

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

Session 12: Drug Master Files

  • Regulatory Basis
  • DMF Submissions
  • Transmittal Letter
  • Administrative Information
  • FDA Review of DMFs
  • Types I, II, III, IV, and V DMFs
  • General Suggestions
  • Letters of Authorization
  • Holder Obligations
  • Transfer of Ownership and Potential Issues
Session 13: The Common Technical Document – An Overview of Modules 1-5
  • Organization of Module
Session 14: Common Technical Document - Module 1
  • Organization and Review of Module 1
Session 15: Common Technical Document: Module 2
  • Organization of Module 2
  • The QOS
Session 16: Common Technical Document: Module 3
  • Content and Requirements

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