What’s new with ISO 14155:2020 GCP?
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This interactive webinar was developed to help you understand the latest elements of the latest version of the new ISO (14155), the International Good Clinical Practice standard for clinical investigations with medical devices. You will learn which and how additions impact the operations of your clinical investigations with medical devices.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Live online training: 2h
Course Description
The European Regulation 745/2017 on medical devices impose that clinical investigations comply with Good Clinical Practice as outlined in the ISO 14155 standard. Recently the 3rd version of this international GCP-standard has been released.This 1,5-hour highly interactive webinar is intended to provide you with the additions compared to the previous version. Also, the impact of the changes in clinical investigations will be presented, by delving into elements such as risk-based quality management, remote monitoring activities, monitoring plan, requirements at different development stages.Be prepared to share any specific questions you may have and benefit from the knowledge of the facilitator as well as the other attendees.Click here for the full ISO 14155 trainingProgramme highlight
- ISO-GCP and ICH-GCP principles
- ISO 14155 and European Regulation 745/2017
- Applicability of requirements in different development stages
- Quality management and risk management principles for clinical investigations of medical devices
- Monitoring activities the new way: risk-based monitoring and monitoring plan
- Clinical investigation audit guidance
Learning objectives
- The aim of the course is to get all the latest ISO-GCP elements clear
- Present key considerations on how to implement new elements, such as risk-based quality management, monitoring the new way, audit preparations
Who should attend
- Clinical Project Managers, Clinical Research Associates, Clinical Trial Assistants
- Previous knowledge of the basics of clinical research, ISO-14155 Good Clinical Practice and ICH Guidelines is expected.
Competencies
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
Amélie Kempeneers
BVI medical
Gert Everaert
Janssen
Anonymous
Acromion