アジェンダ
9:00 AM — 9:30 AM
Welcome and Introductions9:30 AM — 10:15 AM
Session 1: Types of Submissions Affected by CMC10:15 AM — 11:15 AM
Session 2: The Drug Development Process11:15 AM — 11:30 AM
11:30 AM — 11:45 AM
Session 3: Pre-Formulation and Formulation Development11:45 AM — 12:45 PM
Session 4: CMC Requirements for an Investigational New Drug12:45 PM — 1:00 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 19:15 AM — 9:30 AM
Session 5: The EU Investigational Medicinal Product Dossier9:30 AM — 10:00 AM
Session 6: Environmental Impact (IND and NDA)10:00 AM — 10:15 AM
Session 7: Designing the Clinical Trial Material Label10:15 AM — 10:30 AM
10:30 AM — 10:45 AM
Session 8: Special Protocol Assessment10:45 AM — 11:15 AM
Session 9: Drug Master Files (DMF)11:15 AM — 11:30 AM
Session 10: The Common Technical Document - An Overview11:30 AM — 11:45 AM
Session 11: Common Technical Document - Module 111:45 AM — 12:00 PM
Session 12: Common Technical Document - Module 212:00 PM — 12:15 PM
Session 13: Common Technical Document - Module 312:15 PM — 1:00 PM
Session 14: Interactive Workshop - Building a Section of CTD1:00 PM — 1:15 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 29:15 AM — 9:45 AM
Session 15: The NDA Labels9:45 AM — 10:15 AM
Session 16: FDA Briefing Process10:15 AM — 10:30 AM
10:30 AM — 11:15 AM
Session 17: Preparing for CMC Meetings with FDA Exercise11:45 AM — 12:45 PM
Session 19: CMC Inspections - The Pre-Approval Inspection (PAI)12:45 PM — 1:00 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 29:15 AM — 9:45 AM
Session 20: FDA Enforcement Actions - Form FDA 483 and Warning Letters9:45 AM — 10:15 AM
Session 21: Beyond Approval - Post-Approval Changes10:15 AM — 10:30 AM
10:30 AM — 11:00 AM
Session 22: Changes Reportable in an Annual Report11:00 AM — 11:30 AM
Session 23: CMC Considerations in Pediatric Development11:30 AM — 11:45 AM
Wrap-up/Questions and Answers