Course Description

GHTF/IMDRF – International Implementation

Course Description:

This course explores the extent and application of the GHTF/IMDRF regulatory model in a global context. It focuses on both the founding members of GHTF and on other jurisdictions in the process of developing or expanding their regulatory systems.

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Learning Objectives:

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

  • Grasp the breadth and implementation of the GHTF/IMDRF model
  • Understand the structure and alignment of other regulatory systems

Who Should Enroll:

Regulatory affair, quality assurance, and clinical professionals in the industry, and regulators with an interest in the global market are encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Introduction to the GHTF or IMDRF (ID N169)
  • GHTF/IMDRF: The Pre-Market Model (ID N170)
  • GHTF/IMDRF: The Post-Market Model (ID N171)
  • GHTF/IMDRF: Supporting Documents (ID N172)

Subject Matter Expert:
Shelley Tang

35 min

Release date:

Related resources:

Case studies:

Peer review:
Martin de Bruin

Basic Account: € 103.00
Premium Account: € 78.00

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