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Introduction to Drug Development
and the
IND Process
- FDA Organization and Role
- Overview of Drug Development
- Discovery and Development Milestones
- The IND Process
- Special Considerations for IND's
- Recent Changes
- Maintaining IND's
- Key Decisions in Drug Development
- FDA Interactions
- Accelerated Development Options
- Regulatory Intelligence
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Meeting the Regulatory Requirements for
New Drug Applications (NDA's) in the Common Technical Document (CTD) format.
Day 1:
Meeting the Regulatory Requirements for NDA's
- FDA Organization
and Role
- Organization and Content of NDA's and BLA's
in the CTD format
- FDA Review of NDA's and BLA's
- Recent Changes
- Regulatory Intelligence
Day 2:
Preparing for the NDA Submission
A real-time exercise during which the company begins to fill in the Table
of Contents of the NDA, assembles the documents available
thus far and starts to plan for the submission.
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