Course Description

ISO 14155 Version 2003 vs. 2011: Gap Analysis

Course Description:

This course provides a resource document review of the 2003 ISO 14155 version and the major changes applied thereto in the 2011 publication.


Disclaimer: The summary of changes provided in this course are to the best of our knowledge; neither the TC 194 WG4 convener, Danielle Giroud (WMDO), nor the author can be held liable for any of its content when applied by learners to their procedures or daily activities.

Learning Objectives:

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

  • Identify the differences between the 2003 and 2011 versions of ISO 14155

Who Should Enroll:

Professionals involved in clinical investigations, sponsors, monitors, investigators, ethics committee employees, regulatory authorities, and third party reviewers are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.

Subject Matter Expert:
Danielle Giroud

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Change Currency:
Under review !!