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Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs
The ICH E8 (R1) revision is intended to identify and modernize the current conduct of clinical research: Clinical trial design, planning, management, and conduct. The goal of the updated ICH E8 (R1) guidance is to provide flexibility in addressing the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions. This web seminar will describe the ICH E8 (R1) addendum in a step-by-step process and provide a parallel discussion of how the reviewed guideline can improve efficient approaches to trial management. Discussion topics include: A Quality by Design (QbD) approach to the planning, development, and design of a clinical trial; stakeholder engagement during the design and conduct of clinical trials focusing on trial design, recruitment, retention of trial subjects; ethical concerns regarding access to medication post-trial; real-world evidence (RWE) in drug development post-market safety; working with various types of data sources; and the need to leverage more modern technology.
- Describe the ICH E8 (R1) guideline changes
- Explain the impact of the ICH E8 (R1) on clinical trial conduct
- Discuss opportunities for implementing the ICH E8 (R1) guideline in your organization
Who Should Attend
- Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
- Study Managers/Project Managers
- Clinical Research Associates/Monitors
- Regulatory Affairs, Biostatisticians, Data Managers
- Clinical Research Nurses, Clinical Research Coordinators, Clinical Investigators
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.