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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 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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