ICH-GCP (Good Clinical Practice) E6 (R2) Refresher – eLearning
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Date | Product | Location | Price | |
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ICH-GCP (Good Clinical Practice) E6 (R2) Refresher – eLearning | eLearning | EUR 240.00 | Book | |
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 (2) and its implementation and you want to do it in a very practical and useful way? Then this eLearning course is designed for you. How is this course different from other GCP refreshers? It is conducted in a very interactive way to review ICH-GCP through workshops, quizzes and several real-life situations.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Course credit: 4h (3 months period to complete course)
- Complete the course at anytime, anywhere!
Course Description
This interactive eLearning 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 eLearning course that give you immediate 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
- 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
Learning objectives
- 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
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)
Nikenza Viceconte
I had already taken a course in the past on GCP but I needed to refresh a bit the content of the legislation. It is very interactive , I liked it!
Hilde Viane
It has been a very interesting course and I found the real case scenarios very useful. I registered for the touchpoint with the trainer and appreciated the oppportunity to ask my questions and received clarification on specific points.
Kim Simonsen
Galapagos
A very good trainer - The content is important and it's delivered in an optimal way in my opinion.
Natasja Segher
Galapagos
Apart from a few hours training on GCP during my education a few years ago, I was glad to learn so much about gcp and the revisions in this course. through the interactive voting I was not afraid to join and everyone could "think" for him or herself, which contributed massively - interactive game with the color cards for IEC/monitor/sponsor and investigator. that was really making everyone think and it was fun + working in tiny teams - 1day course suffices to get a giant upgrade on your GCP knowledge.
Isabelle Borghini Fuhrer
Medicines for Malaria Venture
Jean-Claude Nzeyimana
IDDI
Thao Pham
IDDI
Genevieve Sturbois
IDDI
Michael Papadimitrious
Miltenyi Biotec