アジェンダ
8:15 AM — 8:30 AM
8:30 AM — 9:15 AM
Welcome, Introduction, and Session 1: Introduction/Overview of FDA9:15 AM — 9:45 AM
Session 2: Types of Submissions Affected by CMC9:45 AM — 10:15 AM
Session 3: The Drug Development Process10:15 AM — 10:30 AM
10:30 AM — 10:45 AM
Session 4: Pre-formulation and Formulation Development10:45 AM — 11:00 AM
Session 5: FDA Briefing Process11:00 AM — 12:00 PM
Session 6: CMC Requirements for an IND12:00 PM — 12:45 PM
12:45 PM — 1:00 PM
Session 7: The EU Investigational Medicinal Product Dossier1:00 PM — 1:20 PM
Session 8: Environmental Impact (IND and NDA)1:20 PM — 1:35 PM
Session 9: Designing the Clinical Trial Material Label1:35 PM — 1:45 PM
Session 10: From Clinical Trial Material to Commercial Product1:45 PM — 2:00 PM
Session 11: Special Protocol Assessment2:00 PM — 2:30 PM
Session 12: Interactive Workshop2:30 PM — 2:45 PM
2:45 PM — 3:30 PM
Session 13: Drug Master Files3:30 PM — 4:00 PM
Session 14: The Common Technical Document - An Overview Module 1-54:00 PM — 4:15 PM
Session 15: Common Technical Document - Module 14:15 PM — 4:30 PM
Session 16: Common Technical Document - Module 24:30 PM — 5:00 PM
Session 17: Common Technical Document - Module 35:00 PM — 5:15 PM
Questions and Answers8:15 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 18: Interactive Workshop9:00 AM — 9:30 AM
Session 19: The NDA Labels9:30 AM — 10:15 AM
Session 20: Preparing for CMC Meetings with FDA10:15 AM — 10:30 AM
10:30 AM — 10:45 AM
Session 21: Designing a Stability Protocol10:45 AM — 11:00 AM
Session 22: Contents of a Certificate of Analysis11:00 AM — 11:45 AM
Session 23: CMC Inspections - The PAI11:45 AM — 12:15 PM
Session 24: FDA Enforcement Actions - Form FDA 483 & Warning Letters12:15 PM — 1:15 PM
1:15 PM — 1:50 PM
Session 25: Beyond Approval - Post-Approval Changes1:50 PM — 2:30 PM
Session 26: Changes Reportable in an Annual Report2:30 PM — 3:00 PM
Session 27: CMC Considerations in Pediatric Development3:00 PM — 3:15 PM
Session 28: References3:15 PM — 3:30 PM
Questions and Answers and Learners Assessment