Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Triet M. Tran, PharmD, BCSCP
Regulatory Officer
Bioresearch Monitoring Branch (BMB)
Division of Inspections and Surveillance (DIS)
Office of Compliance and Biologics Quality (OCBQ)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Lieutenant Triet M. Tran, PharmD, BCSCP, is a regulatory officer in the Bioresearch Monitoring Branch, Division of Inspections and Surveillance, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research. Prior to his work at the FDA, Dr. Tran served as an inpatient pharmacist, nuclear pharmacist, and radiation safety officer. Since joining the FDA in 2021, Dr. Tran has served as a bioresearch and monitoring reviewer, collaborating with different product offices within CBER to review drug applications and with the Office of Regulatory Affairs (ORA) to issue and review inspections. Dr. Tran earned his Doctorate of Pharmacy from the University of Maryland School of Pharmacy in 2018.
Abstract
Lieutenant Triet Tran presents an overview of the FDA CBER BIMO program. This is a comprehensive, FDA-wide program encompassing onsite inspections, data audits, and remote regulatory assessments to monitor the conduct and reporting of FDA regulated studies. The primary objectives are to protect the rights and welfare of subjects, ensure the quality and integrity of data supporting marketing applications, and assess compliance with governing regulations. Within CBER, the program administers various types of inspections, including those focusing on clinical investigators, sponsors, CROs, and IRBs, as well as nonclinical laboratories. These inspections are commonly driven by marketing applications, initiated for cause in response to complaints, or conducted as part of routine surveillance programs. The process involves site selection based on risk, conducting the inspection, issuing an initial classification, and potentially resulting in a final classification of No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI), which can lead to compliance actions. Common violations include failing to follow the investigational plan, inadequate study records, issues with subject protection, and problems with safety reporting or investigational product control. Effective strategies to ensure compliance focus on understanding responsibilities, maintaining organized and accurate records, understanding the protocol, and proactively building quality into the clinical trial process. The BIMO inspection metrics and findings are publicly available.