MCC eLearning Courses – 301

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management [MCCe301]

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.

ACT NOW TO RECEIVE A SPECIAL INTRODUCTORY OFFER ($100 off)

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Prerequisites: None
Length: 1-hour
No. of Attachments: 2

Price*

ACT NOW TO RECEIVE A SPECIAL INTRODUCTORY OFFER ($100 off)

Member: $460
(see MCC Member Homepage or contact MCC)
Non Member: $599

Become a MCC Member today and receive a discounted course price! Visit the MCC website or contact MCC Membership Director, Teresa Holland for more information.

Register Now

 

REGULAR PRICING:
Member: $560
(see MCC Member Homepage or contact MCC)
Non Member: $699
Accreditation: Please contact MCC if you need a Certificate of Completion to obtain ACRP and SOCRA CEUs

*To request an invoice for a course or to purchase access for 10 or more colleagues, please contact Lara Knitter for assistance.

Learning Objectives

Upon successful completion of this course you should 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

Course Outline

  • What is risk? How does risk apply to clinical research?
  • Step-by-step instructions for identifying, evaluating, and managing risk
  • Lessons learned: Overcoming implementation challenges

Course Attachments

  • MCC Quality Risk Management Diagram (PDF)
  • MCC Risk Assessment and Control Log (Excel file)

Who Should Attend

This course 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

Accreditation Information

Please contact MCC if you need a Certificate of Completion to obtain ACRP and SOCRA CEUs

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