Course Description

BIMO: US FDA BIMO Compliance Program

Course Description:

This two-part course covers the significant events that led to the establishment of BIMO, the US FDA Bioresearch Monitoring Program. It examines BIMO’s organizational structure and how its inspections are assigned, managed, and followed up.

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Anticipate what prompts the FDA to conduct clinical investigation audits
  • Understand the issues and enhancements that currently affect the BIMO program

Who Should Enroll:

Clinical project and data managers, senior clinical research associates, biostatisticians, clinical quality and quality managers involved in auditing and quality systems of clinical investigations for medical devices, regulatory managers dealing with FDA inspections, and clinical investigators and study coordinators involved in medical device clinical investigations are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • Effective Monitoring of Medical Device Clinical Investigations (series; IDs 41–48, 59, 56, 50–55, 108, 96)
  • US FDA Investigational Device Exemption (IDE) Overview (ID 121)
  • Auditing Medical Device Clinical investigations (series; IDs 217–219)
  • Clinical Project Management Complete Ten Course Suite (series; IDs 97–106)

Subject Matter Expert:
Barry Sands

54 min

Release date:

Related resources:

Case studies:

Basic Account: € 165.00
Premium Account: € 123.00

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