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Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities
Session Chair(s)
Kassa Ayalew, MD, MPH
Director, DCCE, OSI, Office of Compliance, CDER
FDA, United States
Explore Good Clinical Practice Inspections (GCP) inspections from regulatory and industry views, using FDA data to highlight global trends, compliance strategies, and harmonization, with insights on coverage of sites, sponsors, clinical research organizations (CROs), and regions.
Learning Objective : Recognize FDA GCP inspection scope and trends from FY2016–2018 across US and non-US sites; Compare inspection approaches among regulators; Evaluate opportunities for harmonization and information sharing; Analyze industry strategies for global inspection readiness and compliance.
Speaker(s)
panelist
Thomas Haag
Cardinal Solutions Consuting, LLC, United States
Principal Consultant
Panelist
Izumi Oba
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspection Deupty Director
Panelist
Jong-Hoon Lee, MD
FDA, United States
Senior Physician
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