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Update: FDA CDER's Progress to Adapting Standardized Data to Select Clinical Sites for Inspection
Session Chair(s)
Betsy Fallen, RN
Consultant
BAFallen Consulting LLC, United States
This session will include an overview of the Office Of Scientific Investigation (OSI), discuss the goals of the Bioresearch Monitoring (BIMO) Program, include a review of previous challenges to the inspection system, provide an overview of CDER’s Clinical Site Selection Model and Tool and provide a summary of the OSI request for information specification for preparing and submitting summary level clinical site data in the electronic common technical document (eCTD).
Learning Objective : Describe the content, function, structure and goals of the submission deliverables to support FDA CDER BIMO and their incorporation in the eCTD; Summarize the FDA effort to standardize this request; Discuss the effort of CDISC to incorporate data elements identified by BIMO in the SDTM.
Speaker(s)
Format and Content of FDA Requested Documentation and Datasets to Facilitate Bioresearch Monitoring (BIMO) Inspections
Radius Davenport, PhD
Radius Health, United States
Vice President Regulatory Affairs
FDA Point of View
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
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