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Archive: Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Course Description
ICH GCP E6 R2 provides significant detail on implementing a system of quality management with a focus on a risk-based/risk management approach for the trial, also referred to as Risk-Based Quality Management. This web seminar reviews this new sponsor requirement and describes the clinical quality management system (cQMS) that should be used to oversee quality during the design, conduct, recording, evaluation, reporting and archiving phases – notably the lifecycle of the clinical trial. Additionally, cQMS industry benchmarks, standards and practices will also be discussed.
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Learning Objectives
- Describe two new requirements for the sponsor’s quality management (QM) of clinical trials
- Identify two approaches to achieve compliance with QM for the clinical trial lifecycle
- Determine next steps for evaluation and implementation of the new requirements
Who Should Attend
- Trial Managers
- Project Managers/Directors
- Clinical Quality Assurance/Compliance Personnel
Instructor
Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
