The Association of Clinical Research Professionals
The Drug Development Process Aligning ICH E8 and ICH E6(R3)
Clinical trials are part of a broader drug development journey, with each study building on prior knowledge to support the safe and effective use of a medicinal product.
This 90-minute course introduces the drug development process through the lens of ICH E8(R1) and ICH E6(R3), helping you understand how development plans, trial objectives, and quality-focused decision-making align across the clinical development lifecycle.
You’ll explore how risk-proportionate, quality-by-design approaches—and Critical-to-Quality (CtQ) thinking—support participant safety, reliable results, and operational feasibility in real-world clinical research.
At the end of this course, participants should be able to:
Explain the purpose of the drug development process within a lifecycle framework
Describe how clinical development plans guide individual trial design and execution
Distinguish between clinical trial phases based on objectives rather than labels
Describe factors that influence trial feasibility, including site capabilities and protocol demands
Explain how Quality-by-Design principles support participant safety and data reliability
Recognize how risk-proportionate thinking and Critical-to-Quality factors support effective trial oversight