Agenda
8:30 AM — 8:45 AM
Welcome and Introduction10:45 AM — 12:15 PM
Session 2B: Pharmacopoeias: Collaboration Across Borders1:30 PM — 3:00 PM
Session 3A: Global Supply Chain: Counterfeits1:30 PM — 3:00 PM
Session 3B: Impurities - Genotoxic Impurities1:30 PM — 3:00 PM
Session 3C: Clinical Trials in the European Union (Biologicals)3:30 PM — 5:30 PM
Session 4A: Drug Shortages3:30 PM — 5:30 PM
Session 4B: Impurities - Metal Impurities3:30 PM — 5:30 PM
Session 4C: Clinical Trials Submissions in Asia Pacific Region8:00 AM — 9:30 AM
Session 5: Clinically Relevant Specifications10:00 AM — 12:00 PM
Session 6A: Regional Approaches to Bioequivalence10:00 AM — 12:00 PM
Session 6B: Control Strategy - Lessons Learned10:00 AM — 12:00 PM
Session 6C: Antibody-Drug Conjugates (ADC)1:00 PM — 3:00 PM
Session 7A: Pediatrics: Challenges and Specific Requirements1:00 PM — 3:00 PM
Session 7B: Control Strategy in Continuous Manufacturing1:00 PM — 3:00 PM
Session 7C: Biosimilars3:30 PM — 5:00 PM
Session 8: New Technologies8:00 AM — 9:30 AM
Session 9A: Innovative Approaches for Stability Programs8:00 AM — 9:30 AM
Session 9B: Post-Approval Change Management Protocols8:00 AM — 9:30 AM
Session 9C: Advanced-Therapy Medicinal Products (ATMP)9:45 AM — 11:15 AM
Session 10A: Shipments Monitoring and Temperature Control9:45 AM — 11:15 AM
Session 10C: Drug/Device Combination Products11:30 AM — 12:00 PM
Session 11: Panel DiscussionHave an account?