アジェンダ
8:15 AM — 8:30 AM
8:30 AM — 9:00 AM
Welcome and Introduction to Course9:00 AM — 9:45 AM
Session 1: Types of Submissions Affected by CMC9:45 AM — 10:15 AM
Session 2: The Drug Development Process10:15 AM — 10:30 AM
10:30 AM — 10:45 AM
Session 3: Pre-Formulation and Formulation Development10:45 AM — 11:45 AM
Session 4: CMC Requirements for an IND11:45 AM — 12:45 PM
12:45 PM — 1:00 PM
Session 5: The EU Investigational Medicinal Product Dossier1:00 PM — 1:20 PM
Session 6: Environmental Impact (IND and NDA)1:20 PM — 1:35 PM
Session 7: Designing the Clinical Trial Material Label1:35 PM — 1:45 PM
Session 8: From Clinical Trial Material to Commercial Product1:45 PM — 2:00 PM
Session 9: Special Protocol Assessment2:00 PM — 2:15 PM
2:15 PM — 3:00 PM
Session 10: The Common Technical Document - An Overview3:00 PM — 3:15 PM
Session 11: Common Technical Document - Module 13:15 PM — 3:30 PM
Session 12: Common Technical Document - Module 23:30 PM — 4:00 PM
Session 13: Common Technical Document - Module 34:00 PM — 4:30 PM
Session 14: Drug Master Files (DMF)4:30 PM — 5:00 PM
Session 15: Drug Master File Interactive Workshop5:00 PM — 5:15 PM
Questions and Answers5:15 PM — 6:00 PM
8:15 AM — 8:30 AM
8:30 AM — 8:45 AM
Recap of Day 18:45 AM — 9:15 AM
Session 16: The NDA Labels9:15 AM — 9:45 AM
Session 17: FDA Briefing Process9:45 AM — 10:30 AM
Session 18: Preparing for CMC Meetings with FDA Exercise10:30 AM — 10:45 AM
11:15 AM — 12:15 PM
Session 20: CMC Inspections - The Pre-Approval Inspection (PAI)12:15 PM — 1:15 PM
1:15 PM — 1:45 PM
Session 21: FDA Enforcement Actions - Form FDA 483 & Warning Letters1:45 PM — 2:15 PM
Session 22: Beyond Approval - Post-Approval Changes2:15 PM — 2:30 PM
2:30 PM — 3:00 PM
Session 23: Changes Reportable in an Annual Report3:00 PM — 3:30 PM
Session 24: CMC Considerations in Pediatric Development3:30 PM — 4:00 PM
Questions and Answers and Wrap-up