Agendas
8:30 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 10:15 AM
Session 1: Life Cycle Management10:15 AM — 10:45 AM
10:45 AM — 12:15 PM
Session 02C: Case Studies and Post Approval Change Requirements in Latin America10:45 AM — 12:15 PM
Session 2A: Technology Transfer10:45 AM — 12:15 PM
Session 2B: Post-Approval Change Management Protocols (PACMP)12:15 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3A: Elemental Impurities1:30 PM — 3:00 PM
Session 3B: Quality Metrics3:00 PM — 3:30 PM
8:00 AM — 9:30 AM
Session 05A: Continuous Manufacturing8:00 AM — 9:30 AM
Session 5B: Risk-Based Review8:00 AM — 9:30 AM
Session 5C: Process Validation/Verification - Biologicals9:30 AM — 10:00 AM
10:00 AM — 12:00 PM
Session 06B: Pediatrics10:00 AM — 12:00 PM
Session 6A: Process Validation/Verification - Chemicals10:00 AM — 12:00 PM
Session 6C: Comparability Biologicals12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 7: Implementation of QbD3:00 PM — 3:30 PM
3:30 PM — 5:30 PM
Session 8A: Modelling (Chemicals)3:30 PM — 5:30 PM
Session 8B: FDA/EMA QbD Pilot Program Update3:30 PM — 5:30 PM
Session 8C: Risk Management for Biologicals8:00 AM — 9:30 AM
Session 09B: Breakthrough Therapies8:00 AM — 9:30 AM
Session 9A: API Starting Materials - Implementation9:30 AM — 10:00 AM