ICH E8 (R1) Guideline Course: Clinical Research Best Practices
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About this course
Reasons to Attend
The ICH E8 (R1) Guideline introduces key principles for improving study design, ensuring data quality, safety and applying a risk-based approach to clinical research. Understanding these updates is essential for maintaining regulatory compliance and enhancing the efficiency of clinical trials.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
This course is developed as an eLearning and will be about 30 minutes in length.Course Description
The ICH E8 (R1) Guideline represents a major shift in clinical research, focusing on quality by design (QbD), risk-based approaches, safety and patient-centricity. These updates are critical for improving study design, ensuring high-quality data, and aligning with regulatory expectations.This course provides a comprehensive and practical overview of ICH E8 (R1), helping clinical research professionals integrate its principles into their daily work. You will gain insights into the key changes, learn how to apply risk-based study planning, and explore best practices for ensuring compliance while enhancing trial efficiency.
Whether you are involved in study design, execution, oversight, or compliance, this course will equip you with the essential knowledge to navigate modern clinical research challenges with confidence.
Programme highlight
- Key updates in ICH E8 (R1) including the general principles and why they matter
- Introduction to quality by design (QbD) in clinical trials
- Basics of risk-based approaches in study planning, conducting and reporting
- Drug Development Planning, Design Elements and Data Sources
- Ensuring study quality and compliance with ICH E8 (R1).
Learning objectives
By the end of this course, participants will:
- Understand the main changes in ICH E8 (R1)
- Recognize the role of quality by design (QbD) in clinical research
- Understand the importance of patient-centered trial design in combination with the integration of innovative approaches
- Be aware of risk-based considerations in study design
- Know how to apply key principles to improve study quality, data integrity and compliance
Who should attend
This ICH E8 (R1) Guideline course is designed for all professionals who play a role in the design, implementation, management, or oversight of clinical trials; who need the knowledge to ensure trials are scientifically valid, ethical sound and compliant with regulatory guidelines:
- Clinical Research Associates (CRAs) & Project Managers – To enhance study design and risk-based monitoring approaches.
- Investigators & Site Staff – To ensure compliance with modern study quality expectations.
- Regulatory & Quality Assurance Professionals – To align clinical trials with evolving regulatory standards.
- Pharmaceutical, Biotech & CRO Professionals – To implement efficient and high-quality clinical research practices.
Competencies
Trainers
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