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Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox
Session Chair(s)
Jan Hewett, BSN, JD
Regulatory Counsel for Policy, OSI, CDER
FDA, 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
Kavita C. Dada, PharmD, RAC
FDA, United States
Associate Director of Regulatory Operations, OSI, OC, CDER
Health Canada Update
Jennifer Evans
Health Canada, Canada
Compliance and Enforcement Specialist
Industry Perspective on Remote Assessments
James Riddle
Advarra, United States
Senior Vice President, Global Review Operations
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