Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Emily Gebbia, JD
Associate Director for Regulatory Development
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Emily Gebbia is the Associate Director for Regulatory Development in the Office of Scientific Investigations (OSI) in the FDA’s Center for Drug Evaluation and Research, Office Compliance. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of regulations and guidance related to good clinical practice, human subject protection, and postmarketing safety. Emily prepares and provides technical input on various reports, correspondence, and Congressional inquiries affecting OSI’s programs and works on internal business process improvements and internal and external communications. Prior to joining FDA, Emily was an attorney at Hogan Lovells, advising a range of health sector clients, and a law clerk for the Hon. Richard C. Tallman of the Ninth Circuit Court of Appeals. Emily holds a J.D. from Catholic University of America, Columbus School of Law.
Abstract
Emily Gebbia outlines the FDA’s evolving strategies for evaluating Good Clinical Practice (GCP) compliance, adapting to the increasing globalization and complexity of clinical trials. While on-site inspections remain foundational, the FDA now employs alternative approaches to bolster oversight. She details Remote Regulatory Assessments (RRAs), which are remote examinations of regulated establishments or their records. RRAs are not traditional inspections and do not involve physical entry or the issuance of Forms FDA 482 or 483, though written observations may follow. These assessments can be mandatory or voluntary, with the FDA typically requesting voluntary participation from clinical investigators. Gebbia stresses the importance of preparedness for RRAs, advocating for dedicated teams, clear communication, organized documentation, and appropriate technological infrastructure. Furthermore, she highlights the FDA’s extensive collaborations with foreign regulatory counterparts to improve global oversight and resource efficiency, a necessity given the significant number of international clinical trial participants. Finally, Gebbia addresses the FDA’s approach to innovative trial designs, including those incorporating real-world data, digital health technologies, and decentralized elements. She emphasizes that GCP regulations apply regardless of design, underscoring the critical role of quality by design and quality risk management in ensuring participant safety and data reliability in these modern trials.