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Sessions 12, 13, 14, 15, and 16
Session Chair(s)
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
- Organization of Module
- Organization and Review of Module 1
- Organization of Module 2
- The QOS
- Content and Requirements