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Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA
The FDA and EMA describe their expectations for risk-based approaches to quality management and monitoring in the ‘FDA Guidance Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring’ and the ‘EMA Reflection Paper on risk-based quality management in clinical trials,’ both of which are reviewed in this web seminar, which also includes industry think tank contributions.
- Discuss the FDA Guidance and EMA Reflection Paper for clinical trial risk management and monitoring
- Evaluate industry think tank trends (TransCelerate, CTTI)
- Review best practices for risk management for trial oversight and monitoring
Who Should Attend
- Clinical Investigators and Staff
- Clinical Research Associates
- Study and Clinical Research Associate Managers
- Sponsors/CROs Clinical Operations
- Clinical Quality Compliance and Quality Assurance Professionals
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.