ICH E8 Developments: <em>Are You Sure You’re Up to Date?</em> : Webinar - Nov. 19, 2019
“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) set to be adopted in June 2020, your planning, design and conduct of clinical trials will look different than they do today. Make sure you’re ready to implement the new guidelines. This webinar clarifies how.
Leslie Sam — Principal Consultant with Wool Consulting Group and more than 20 years’ experience as a clinical research and quality professional — will share ways to leverage the revised guidelines’ quality-by-design approaches, expanded study designs and data source considerations.
Ms. Sam will explain ICH E8 updates and guide you through assessing the impact of key concepts to current and future clinical development practices, including the framework and approaches for identifying quality-by-design and critical-to-quality factors. She’ll review these and other expectations as well as their impact to current research practices.
- The purpose of the ICH E8 guideline and its relationship to other ICH Efficacy guidelines, including ICH E6(R2) (Good Clinical Practice [GCP]) and ICH E9 (Statistical Principles for Clinical Trials)
- The impact to current research practices that could influence your SOPs, procedures, processes and documentation pertaining to ICH guidance
- The framework and approaches for determining factors critical to quality with corresponding examples that you can implement, including achieving fit-for-purpose data quality — one of the essential considerations for all clinical studies
- The clinical development areas that may be impacted by the adoption of ICH E8(R1), including those leading to efficient and timely decisionmaking
Prepare for ICH E8(R1) now. Avoid the risk of being left behind. Join us by registering today.
Who Will Benefit
- Regulatory Affairs Professionals
- Clinical Operations Personnel
- Project Managers
- Quality Professionals
- Compliance Professionals
- Clinical Development Professionals
Meet Your Presenter:
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.