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2023 PRIM&R Annual Conference

FDA Regulated Research

F02 - [IN-PERSON ONLY] FDA Remote Regulatory Assessments (RRAs): Another Tool for Regulatory Oversight

Wednesday, December 6, 2023
10:15 AM – 11:15 AM ET
Location: Room 158 AB
Human Subjects Research Deep Dive Series
This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

This session will discuss how FDA uses RRAs to assess establishments and their compliance with applicable FDA requirements. The session will focus on the use of RRAs during the COVID-19 pandemic and outside of the pandemic. Relevant guidance and resource materials will be reviewed with specific discussion on BIMO program areas where RRAs have been conducted.

Learning Objectives:

  • Describe what a RRA is comprised of, including the steps taken before, during, and after the RRA is concluded
  • Explore the current draft Guidance for Industry–Conducting Remote Regulatory Assessments, Questions and Answers
  • Review FY22 Bioresearch Monitoring Program Information (BIMO) Metrics and the number of alternative activities conducted in BIMO program areas