Foundational ICH-Good Clinical Practice (GCP) E6 (R3) – eLearning (COMING SOON)
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About this course
Reasons to attend
Did you know that your clinical investigations need to comply with the ICH GCP E6 (R3) guideline? Enhance your expertise with our course on the updated ICH GCP E6 (R3) guideline. This informative training provides a comprehensive overview of the entire document, ensuring that you are fully equipped to meet the latest Good Clinical Practice standards. You will gain in-depth knowledge of essential GCP principles, including the implementation of risk-based approaches and the importance of data integrity. This course is designed to empower professionals to navigate regulatory requirements effectively, foster a culture of compliance and excellence in clinical trials.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 month period to complete course)
- Complete the course at anytime, anywhere!
Course Description
This course covers all the ICH-GCP in its current version (R3) and will cover the responsibilities of every stakeholder involved, as well as its implementation in practice. Without training on the ICH-GCP requirements, or without experience in clinical research, professionals are not always aware of the legal regulations that govern clinical studies, including post-marketing trials. ICH-GCP is the guideline ruling all clinical research including its conduct, performance, monitoring and reporting of the results. This course focuses on the requirements of GCP in clinical studies with pharmaceuticals. During the course, participants will gain a thorough understanding of the entire ICH GCP E6 (R3) guideline, focusing on both foundational principles and recent updates. You will learn how to effectively implement risk-based strategies in clinical trials, enhancing efficiency and compliance while maintaining participant safety. The course also delves into quality management principles, emphasizing the importance of data integrity and governance in today’s digital landscape. This training is ideal for all clinical research professionals who are committed to maintaining compliance and excellence in their work. By the end of the course, you will be well-prepared to navigate regulatory requirements confidently and implement effective strategies that improve trial outcomes. Join us to deepen your understanding of ICH GCP E6 (R3) and elevate your contributions to clinical research.Programme highlight
- Comprehensive overview of ICH GCP E6 (R3) guideline
- In-depth exploration of new sections and structural changes
- 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
- Practical application of updated GCP principles
- Case studies and interactive sessions on implementing R3 guidelines
Learning objectives
By the end of this course, participants will be able to:
- Understand and explain the key changes in ICH GCP E6 (R3)
- Apply risk-based quality management principles to clinical trial processes
- Implement strategies to ensure data integrity and governance
- Navigate the new structure of the R3 guideline, including annexes and appendices
- Adapt clinical trial practices to align with updated sponsor and investigator responsibilities
- Incorporate flexibility and adaptability in trial design while maintaining compliance
- Evaluate and update existing processes to meet R3 requirements
- Demonstrate proficiency in applying GCP principles in various clinical trial scenarios
Who should attend
Any professional within clinical research; investigator; monitor; study coordinator or other staff that need to gain foundational knowledge about and comply with the current GCP standard. No 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 (3)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (2)
- Data Management and Informatics (5)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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