アジェンダ
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Introduction8:45 AM — 9:30 AM
Session 1: Quality and the Quality System9:30 AM — 10:15 AM
Session 2: Quality Management System Overview10:15 AM — 10:30 AM
10:30 AM — 11:15 AM
Session 3: The Pharmacovigilance System11:15 AM — 12:00 PM
Session 4: Systems, Processes, Quality Documents12:00 PM — 1:00 PM
1:45 PM — 2:30 PM
Session 6: Risk Assessment of Identified Gaps2:30 PM — 2:45 PM
2:45 PM — 3:45 PM
Session 7: Procedures and Standards3:45 PM — 4:45 PM
Session 8: Pharmacovigilance in the Study and Clinical Trial Environment4:45 PM — 5:00 PM
Questions and Answers and Daily Wrap-Up8:00 AM — 8:30 AM
8:30 AM — 9:15 AM
Session 9: Pharmacovigilance Agreements (PVAs) and PV Provisions9:15 AM — 10:00 AM
Session 10: Commercial Activities and PV Obligations10:00 AM — 10:15 AM
10:15 AM — 11:00 AM
Session 11: Compliance Management and Monitoring11:00 AM — 12:00 PM
Session 12: Risk-Based Auditing and the Pharmacovigilance Audit Universe12:00 PM — 1:00 PM
1:00 PM — 1:45 PM
Session 13: Record Management and Documentation of QMS1:45 PM — 2:30 PM
Session 14: Pharmacovigilance Inspections and Inspection Readiness2:30 PM — 2:45 PM
2:45 PM — 3:30 PM
Session 15: Responding to Inspection and Audit Findings3:30 PM — 4:15 PM
Session 16: Corrective and Preventive Action (CAPA) Plan4:15 PM — 4:30 PM
Session 17: Pharmacovigilance QMS Course Summary and Q & A4:30 PM — 4:45 PM
Course Evaluation and Post Test