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Risk-Based Quality Management and Monitoring: Practical Approaches
Session Chair(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States
In this session industry speakers will present their real-world experience with clinical trial oversight by discussing: 1) Case histories explaining audit and inspectional findings that identified significant compliance gaps, how findings were addressed, and proposals created to prevent similar findings in future studies, 2) Implementation of risk-based quality management and risk-based monitoring systems, 3) How the COVID-19 Pandemic has accelerated and transformed monitoring strategies, including use of centralized and remote monitoring strategies, and 4) Risk-based monitoring strategies used in a large COVID-19 Vaccine Trial and implications for successful implementation in future studies.
Learning Objective : Identify the importance of risk-based quality management and risk-based monitoring systems in clinical trial oversight; Describe the importance of good corrective and preventive action planning and how it functions as an integral part of your risk-based quality management system; Discuss how the COVID-19 Pandemic has accelerated innovation and spurred the use of risk-based monitoring strategies, including centralized statistical monitoring and remote monitoring strategies.
Speaker(s)
Lessons Learned: Ensuring Electronic Systems Used in Clinical Trials Meet Data Integrity Requirements
Kelly Simpliciano, MS
Bristol-Myers Squibb Company, United States
Associate Director, Research Development Quality - Clinical Trials Systems & Aud
Long-Term Site Monitoring Transformation Resulting from Critical Evaluation Brought About by COVID-19 Pandemic
Mary Arnould, BSN, MSN
Astellas, United States
Director, Clinical Science Operations
Driving a Culture of Quality Through Risk-Based Monitoring on the Mega-COVID19 Vaccine Trial: A Case Study
Crupa Kurien
Pfizer Inc, United States
Central Monitoring Manager, Risk Based Monitoring, Data Monitoring & Management,