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The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India
Session Chair(s)
Leslie Ball, MD
Assistant Commissioner and Deputy Director, OIP, OC
FDA, United States
This panel will use a case study format and present the risk-based approach used to select sites for inspection and discuss the role of FDA’s international offices in facilitating inspections and engaging with regulatory counterparts in country. The forum will review violations that called into question the accuracy of data, and discuss the impact to drug applications.
Learning Objective : Identify the risk-based approach for selecting firms for inspection and define the role of FDA’s international offices in inspections; Describe inspectional findings of a bioequivalence/bioanalytical firm in India that demonstrated significant violations impacting data quality; Discuss the process for considering regulatory impact of inspectional findings and implementing follow up actions.
Speaker(s)
Panelist
Sean Kassim, PHD
FDA, United States
Director, Office of Study Integrity and Surveillance, OTS, CDER
Panelist
Mathew Thomas, MD
Healthcare Innovation Catalysts, United States
Senior Regulatory and Clinical Advisor
Panelist
Arindam Dasgupta, PHD
FDA, United States
Deputy Director, Division of New Drug Bioequivalence, OSIS, OTS, CDER