アジェンダ
8:00 AM — 5:00 PM
CMC Short Course7:45 AM — 8:15 AM
8:15 AM — 8:30 AM
Welcome Remarks8:30 AM — 10:30 AM
Session 1: Innovation and New Technologies – Challenges and Opportunities10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2A: Drug/Device Combinations11:00 AM — 12:30 PM
Session 2B: Process Validation/Process Verification12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3A: Contract Manufacturing (Part I)1:30 PM — 3:00 PM
Session 3B: Enhanced Control Strategy3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4A: Contract Manufacturing (Part II)3:30 PM — 5:00 PM
Session 4B: Medical Errors Due to Product Design and Development5:00 PM — 6:00 PM
8:00 AM — 9:30 AM
Session 5: Regulatory Harmonisation9:30 AM — 10:00 AM
10:00 AM — 12:00 PM
Session 6A: Post Approval Changes - ICH Q1212:00 PM — 1:00 PM
1:00 PM — 2:30 PM
Session 7A: Leveraging Prior Knowledge During Lifecycle1:00 PM — 2:30 PM
Session 7B: Biologics: Monographs and Standardisation2:30 PM — 3:00 PM
3:00 PM — 5:00 PM
Session 8: Updates from Health Authorities