MCC Risk Assessment & Mitigation Management Tool 2.0: Risk-Based Quality Management Aligned with ICH E6 (R2)

MCC’s Risk Assessment & Mitigation Management Tool 2.0 provides a roadmap for implementing and executing a formal approach to risk-based quality management through three key risk management stages: Risk Assessment, Risk Mitigation and Control, and Issue Management – fully supporting the process described in the ICH E6 (R2) guidance. The tool includes a risk evaluation process that begins with establishing critical data, processes and the risks related to those rather than having users score a long list of potential risks. Additionally, it prompts users to consider pre-study risk reduction and issue mitigation management planning and reporting. Learn how the tool can help take your organization to the next level of risk-based quality management.