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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  6. Office of Bioresearch Monitoring Inspectorate (OBMI)
  7. Christine Smith
  1. Office of Bioresearch Monitoring Inspectorate (OBMI)

Christine M. Smith
Leadership Role

Christine M. Smith

Christine M. Smith is the Program Division Director for the Division of Bioresearch Monitoring Operations East (BIMOE) which is part of the Office of Bioresearch Monitoring Operations within the Food and Drug Administration’s Office of Regulatory Affairs.  She is responsible for a group of professional investigators, supervisors, and support staff who work with each of FDA’s product centers performing inspections of clinical and non-clinical trials, post-market adverse drug experiences, and risk evaluation and mitigation strategies. 

Ms. Smith has been with FDA/ORA since 1992 and holds a Bachelor of Science in Biochemistry and Molecular Biology from UMBC in Baltimore, MD. She started as a student trainee physical science technician in the former Baltimore District Laboratory, and has been a chemist, investigator, bioresearch monitoring specialist, training officer, supervisor, special assistant to the deputy associate commissioner for regulatory affairs, and director of investigations throughout her career. Christine is enthusiastic about continuous improvement and collaboration to promote efficiencies and best practices. 
 

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