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Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

An MCC FREE Webinar
Thursday, Oct. 18, 2018 • 11:00 a.m. - 12:00 p.m. EDT

Are the scale… complexity… and costs of your clinical trials increasing?

Since the release of the ICH GCP Guidance updates, your answer is most likely — yes.

And, you — like many sponsors and their partners — might have limited experience with risk-based quality management approaches.

Mark your calendar for Thursday, Oct. 18, when Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will discuss approaches sponsors are taking to align with ICH E6(R2).

During 60 fast-paced minutes Linda and Keith will:

  • Explore new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • Discuss the importance of critical thinking in risk assessment and risk control
  • Explain the meaning of high and low detectability and the relevance to risk prioritization
  • Describe leading practices to improve risk assessment and quality oversight

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 … and it’s FREE. Sign up now.

Who Will Benefit

This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Clinical Operations/Management/ Research/Development
  • Clinical Outsourcing/Vendor Management/Third-Party Management
  • Clinical/Project Operations
  • Performance Analytics/Management/Reporting
  • Metric Reporting/Visualization
  • Quality Management/Clinical Quality Management
  • Compliance/Clinical Compliance/ Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Risk Assessment
  • Centralized Monitoring / Risk-based Monitoring
  • Good Clinical Practices
  • Clinical Process Optimization
  • Vendor Oversight

Sign Up for FREE Below

Meet Your Presenters

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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 association 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.

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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.