ISO 14155 VERSION 2011 VS 2020 GAP ANALYSIS
The document represents a review of ISO 14155 version 2011 and major changes applied thereto with the publication of the version Iso 14155:2020. The summary of changes are provided here to the best of our knowledge, although produced by the convener of the TC 194 WG4, Danielle Giroud, WMDO, nor Danielle Giroud can be held liable for any of its contents when applied by readers in their procedures or daily activities.
Upon successfully completing this course, learners will be able to:
- Identify the differences between the 2011 and 2020 versions of ISO 14155
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.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.