ICH-Good Clinical Practice (GCP) E6 (R3) Refresher – eLearning (Coming Soon)
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| 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
Do you need to update and to refresh your knowledge on the current ICH-GCP E6 (R3) and its implementation and you want to do it in a very practical and useful way? Then this 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 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: To be determined (3 months period to complete course)
- Complete the course at anytime, anywhere!
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 stakeholders 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 globally recognised certification can be found on our Virtual Campus.
Programme highlight
- Comprehensive overview of ICH GCP E6 (R3) guideline
- In-depth exploration of the new structure, including principles and annexes
- Analysis of key differences between R2 and R3
- Focus on risk-based approaches and quality management
- Discussion on data integrity and governance in clinical trials
- Examination of updated responsibilities for IRB/IEC, investigators, and sponsors
Learning objectives
By the end of this course, participants will be able to:
- Describe the new principles of ICH GCP E6 (R3)
- Discuss risk-based quality management principles in clinical trial processes
- Recognize strategies to ensure data integrity and governance
- Identify the new structure of the R3 guideline, including annexes
- Outline updated sponsor and investigator responsibilities
- Describe approaches for incorporating flexibility in trial design while maintaining compliance
- Recognize areas where existing processes may need updates to meet R3 requirements
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)
Trainers
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