Mastering Risk Management

Recent updates included in ICH E6 (R2) section 5 (Quality Management) mean that the quality management methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected.

But … does your organization understand risk and how to implement risk management in your clinical research program?

You — like many sponsors and their partners — might have limited experience with using risk-based quality management approaches in clinical research.

Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will teach you to how to develop and implement risk-based quality management programs to comply with new ICH-E6(R2) section 5.0 regulatory updates.

During this on-demand, hands-on 60 minute session, Linda and Keith will walk through risk management concepts and learners will apply the concepts by reviewing a case example and completing the risk assessment and control log included in the course material. At the conclusion of the course, learners will be able to:

• Explain the concept of risk and its management
• Describe risk management in clinical research and the relevance of ICH E6 (R2)
• Identify critical data and processes and use process maps to identify areas of risk
• Develop risk statements and evaluate risk
• Describe approaches to controlling risks in clinical research
• Mitigate some common implementation challenges

You have to develop and implement risk-based quality management programs to comply with ICH E6(R2). You owe it to yourself to discover how.

Meet Your Trainers

Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium
Ms. Sullivan is Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry consortium dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations improve processes to improve financial and quality outcomes.

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd
Keith Dorricott has a background in manufacturing from Kodak Ltd. He has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma and is an expert in root cause analysis. He acts as facilitator for the MCC work groups including Vendor Oversight and Centralized Monitoring.