Course Description

BIMO: IDE Sponsor Obligations

Course Description:

This course focuses specifically on the sponsor’s responsibilities during clinical studies with investigational medical devices in the US. It provides a comprehensive illustration of the areas the US FDA reviews during bioresearch inspections and outlines common deficiencies identified by the US FDA.

Watch the Course Trailer:

 

 


Learning Objectives:

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

  • Distinguish the areas the US FDA reviews during bioresearch monitoring visits to sponsor locations
  • Recognize and define the regulatory pathways where human clinical research involving investigational medical devices is obtained
  • Demonstrate how the ISO 14155: 2011 standard relates to the US FDA BIMO program and why clinical sites located outside of the US must comply with US FDA regulations

Who Should Enroll:

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


Prerequisite Knowledge/Requirements:

The following material is required:

  • A full understanding of good clinical practice and all processes involved in clinical investigations
  • 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 10 Course Suite (series; IDs 97–106)
  • BIMO: US FDA BIMO Compliance Program (ID 143)

Subject Matter Expert:
Barry Sands

Duration:
180 min

Release date:
12/13/2010

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 549.00
Premium Account: € 411.00

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