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Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations
Session Chair(s)
Jenn Sellers, MD
Chief, GCP Assessment Branch, FDA, United States
Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends, highlighting compliance patterns, regulatory harmonization, and industry strategies for sustaining quality in complex global trials
Learning Objective : Examine GCP inspection classification and outcomes across regulatory agencies, highlighting similarities and differences in enforcement; Identify common deficiency patterns and regulatory expectations across regions, emphasizing protocol adherence, recordkeeping, and data integrity; Recognize the impact of inspection observations on regulatory decisions; Discuss industry best practices.
Speaker(s)
Rachel Mead
Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Overview of MHRA's GCP Inspections
Representative Invited
, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Overview of GCP Inspections in Japan
Representative Invited
Senior Physician, OC, CDER, FDA, United States
Decoding GCP Inspection Results: From US FDA 483 Observations to Final Outcomes
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