ICH-GCP E6 (R2) Refresher
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
You need to update and to refresh your knowledge on the current ICH-GCP E6 (R2) and its implementation and you want to do it in a very practical and useful way?Then this course is designed for you.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Half Day face-to-face | Online: 1 webinar session of 3 hours |
Course Description
This interactive course is designed for professionals who already have knowledge of the International Council on Harmonization and Good Clinical Practice (ICH-GCP) standard but need to be up to date. It is designed as a refresher and will cover the responsibilities of all players in the clinical research field. This refresher session is a very innovative course which will allow you to verify the extend of your knowledge on ICH-GCP and complete the potential gap. Interactive quizzes and exercises are included in our course that give you feedback on your comprehension. This will help you to maximise your learning journey. You will be able to test your comprehension with a final grading test. Extra information, updates and your Transcelerate globally recognised certification can be found on our Virtual Campus.Programme highlight
- Refreshing Definitions and Principles of GCP
- Responsibilities for all involved persons/parties
- The essential GCP-related documents
- Impact of the 2016 GCP addendum for Investigators and for Sponsors
- GCP Audit Findings at the Sponsor and at the Investigational Sites
Learning objectives
- Refresh your knowledge on current GCP requirements in clinical research and how they are implemented
- Interpret the essential documents of clinical studies
- Grasp what GCP implies for you in your daily work
- Obtain a clear view on the items added by the Addendum 2016
- Learn how to avoid findings in case of audit and/or inspection
Who should attend
Everyone who needs to refresh their knowledge of the current rules of GCP in clinical studies. Prior training or working experience in a GCP environment is required.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (2)
- Data Management and Informatics (3)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
No testimonial yet