Introduction to the GHTF or IMDRF
This course introduces the Global Harmonization Task Force (GHTF)—now referred to as the International Medical Device Regulatory Forum (IMDRF)—and outlines its goals, organizational process, and recommendations for a harmonized regulatory model. It also looks at the future of global harmonization.
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Upon successfully completing this course, trainees will be able to:
- Understand the structure and functions of the GHTF/IMDRF
- Grasp the basic concepts of its recommendations for a harmonized regulatory system for medical devices
- Apply the mechanisms for carrying such recommendations forward
Regulatory affair, quality assurance, and clinical professionals in the industry, and regulators with an interest in the global market are all welcome to participate in this course.
There is no prerequisite knowledge required for this course; it is an introductory course for regulatory professionals.