ICH E6 (R2) GCP regulations explicitly require a risk-based approach to quality management. However, the challenges faced by small and mid-sized research organisations in effectively adopting Risk-Based Monitoring (RBM) and ensuring R2 compliance can be significant.
In this interactive workshop we will take you through the practical steps involved in conducting an effective and compliant Protocol Risk Assessment. In addition we’ll be taking you through our interpretation of the recently published E8 (R1) draft guidelines, which like E6 (R2) places an important emphasis on risk management.
The workshop will be conducted by subject matter experts from Klifo and TRI, who between them have conducted dozens of Protocol Risk Assessments for Sponsors and CROs.
We’ll also be giving the first demos of of our new Risk Management Tool which delivers process-driven, R2 compliant, end-to-end risk management for clinical trials.