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“The quality by design approach to clinical research (section 3.1) involves focusing on critical to quality factors to ensure the protection of study subjects, the generation of reliable and meaningful results, and the management of risks to those factors (section 3.2).”
— General Considerations for Clinical Studies E8(R1)
With ICH E8(R1) adopted, your planning, design and conduct of clinical trials looks different. Make sure you’re ready to implement the new guidelines.
The Revised ICH E8: A Guide to New Clinical Trial Requirements management reportexplains the ICH E8 updates and guides you through assessing the impact of key concepts on current and future clinical development practices, including the framework and approaches for identifying quality-by-design and critical-to-quality factors. The report reviews these and other expectations:
- The scope and general principles of the ICH E8(R1) guideline
- The impact on current research practices and influences on SOPs, procedures, processes and documentation
- The framework and approaches for identifying critical-to-quality factors
- Clinical development areas that may be impacted by the adoption of the ICH E8(R1) guideline and approaches for compliance
Prepare for ICH E8(R1) now.
About the Contributor
Leslie Sam is Principal Consultant, Wool Consulting Group, supporting the development and refinement of clinical quality management systems, issue management and clinical trial risk management in clinical research. She is an accomplished, results-driven and passionate clinical research and quality professional with 20+ years of transferable technical and leadership skills and business acumen. Ms. Sam has Six Sigma Black Belt certification (CSSBB) and Quality Improvement Associate certification issued by the American Society for Quality. She is co-author of three TransCelerate Group peer-reviewed journal articles on the topics of clinical quality management systems and issues management systems.
Who Will Benefit
- Regulatory Affairs Professionals
- Clinical Operations Personnel
- Project Managers
- Quality Professionals
- Compliance Professionals
- Clinical Development Professionals
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Contributor:
Leslie Sam
ISBN-13:
978-1-60430-122-9
Publication date:
March 2019
Page count:
99
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