Date: 17 October 2024
Time: 14:00 – 18:00 CEST | 9 AM – 1 PM EDT
Location: Virtual
Price: € 595,- | $ 643.-
Introduction
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects. The ISO 14155:2020 standard addresses GCP for medical device studies. Studies in Europe must comply with the standard, and the standard is also recognized by the US FDA and many other regulatory authorities around the globe. This training provides an introduction into the ISO 14155 standard and GCP principles for medical device studies.
Audience
Professionals in the medical device industry who are new to GCP and clinical studies and want to understand the basics of GCP and how studies with medical devices can be designed, conducted, recorded and reported in compliance with ISO 14155.
Learning Objectives
- Understand the scope of the ISO 14155 standard and why compliance is important
- Learn about the Good Clinical Practice (GCP) principles
- Understand the roles of the Sponsor and Principal Investigator
- Learn the basics about the design, conduct, recording and reporting of clinical investigations with medical devices in human subjects according to ISO 14155.