Protocol Risk Assessments aren’t optional. ICH E6 (R2) GCP regulations explicitly require a risk-based approach to quality management and a key part of that is the protocol risk assessment.
However, in our experience, the challenges faced by research organisations in effectively adopting Risk-Based Monitoring (RBM) and ensuring R2 compliance can be significant. For example. over 70% of the companies we surveyed last year were not completing risk assessments on every trial. Why not? R2 compliance isn’t optional. If you needed proof, the regulatory authorities have recently forced companies to retrospectively complete protocol risk assessments. It’s much better, and easier to do it right, right from the start.
In this free webinar we’ll show you how and make risk assessment simple for you.
Click here to book your place today.
Tuesday 26th Feb, 3pm GMT.