アジェンダ
7:30 AM — 8:30 AM
8:15 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 10:15 AM
Session 1: Accelerated Programs10:15 AM — 10:45 AM
10:45 AM — 12:15 PM
Session 2A: Joint Inspections10:45 AM — 12:15 PM
Session 2B: QbD Approaches to Accelerated Drug Development10:45 AM — 12:15 PM
Session 2C: Drug/Device – Part 1: Human Factors Studies12:15 PM — 1:30 PM
1:30 PM — 3:30 PM
Session 3: Innovative Technologies3:30 PM — 4:00 PM
4:00 PM — 5:30 PM
Session 4B: Dissolution Techniques Challenges4:00 PM — 5:30 PM
Session 4C: Drug/Device – Part 2: Technical Challenges5:30 PM — 6:30 PM
7:00 AM — 8:00 AM
8:00 AM — 10:00 AM
Session 5C: Drug/Device – Part 3: Global Regulatory Updates10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 6: ICH Q12 Life Cycle Management: Benefits and Challenges12:00 PM — 1:30 PM
1:30 PM — 3:30 PM
Session 7B: Biosimilars3:30 PM — 4:00 PM
4:00 PM — 5:30 PM
Session 8B: Update on ICH M9 Gaps4:00 PM — 5:30 PM
Session 8C: Regional Updates – Part 2: Asia-Pacific7:00 AM — 8:00 AM
8:00 AM — 9:30 AM
Session 9A: Process and Product Monitoring for Sustained Quality8:00 AM — 9:30 AM
Session 9C: Regional Updates – Part 3: Middle East9:30 AM — 10:00 AM
10:00 AM — 12:00 PM
Session 10: Regulators Update