Elena Boley
FDA, United States
Senior Physician, OSI, OC, CDER
Dr. Boley is a senior physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators primarily for NDAs/BLAs reviewed by the Division of Antivirals and the Division of Psychiatry. As a board-certified internist, she serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials. She is also an Associate Clinical Professor at GWU’s school of medicine and has 20 years of clinical practice experience.
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