Course Description
Focused on the regulatory application of Drug Master File (DMF)
to the U.S. FDA, this two-day course will introduce the elements in
preparation for DMF applications including the detailed requirements on
content, format, assembly, delivery. Participants will gain the
necessary knowledge and practical skills in DMF application procedure.
In addition, the course will introduce FDA抯 review
procedure on DMFs and how to deal with post-application issues, e.g.
amendments, updates, closure, and reactivation.
Course Outline
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Basic Introduction of DMFs
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What is DMF?
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Types of DMFs
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Contents Included in DMFs
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Transmittal letters
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Administrative information
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DMF contents (Type I to Type V)
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DMF Format and Assembly
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DMF Submission
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Appointment of a DMF agent
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Responsibilities of DMF owner
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FDA Review of DMF Package
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DMF Post-application Issues
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Authorization to refer to a DMF
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Annual update
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Amendments
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Close a DMF
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Reactivate a DMF
Who Should Attend?
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Managers, technical staff for QA and QC, and regulatory affair personnel for API companies
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Technical staff for QA and QC, and regulatory
affair personnel for packaging material, excipient, colorant, flavor
essence companies
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Managers and staff in all levels of government Food and Drug Administrations
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Administrators and researchers in medical schools, pharmacy schools, biomedical research and academic institutions
