Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities
Thursday, June 18, 2026 8:00 AM to 9:00 AM · 1 hr. (America/New_York)
TBD
02: ClinicalTrialOps-Innovation09: RD-Quality-Compliance
Information
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.
CE
ACPECMERN
Session Level
Intermediate
Learning Objectives
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.
