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Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox
Session Chair(s)
Jan Hewett, BSN, JD
SVP, FDA Regulatory Advisor, Advarra, United States
This session will describe the evolution of remote regulatory assessments (RRA’s), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program
Learning Objective : Describe what a remote regulatory assessments is and FDA’s authority to conduct a remote regulatory assessment; Describe the steps taken by the agency and site before, during, and after a remote regulatory assessment is conducted; Discuss FY23 metrics including recently conducted remote regulatory assessments.
Speaker(s)
FDA Update
Associate Director for Regulatory Operations, OSI, OC, CDER , FDA, United States
Health Canada Update
Compliance and Enforcement Specialist, Health Canada, Canada
Industry Perspective on Remote Assessments
Senior Vice President, Global Review Operations, Advarra, United States
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