Join KLIFO and TRI’s masterclass in Risk-Based Monitoring and ICH E6 (R2) Compliance – 5th March. Copenhagen
This is an important event because ICH E6 (R2) GCP regulations explicitly require a risk-based approach to quality management. However, in our experience, the challenges faced by small and mid-sized 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. One of the stories you’ll hear on the day is how the regulatory authorities have recently forced companies to retrospectively complete protocol risk assessments.
In the morning session, we and our partners Klifo will demonstrate RBM technology in action and share real-world examples and best practice in overcoming those challenges from more than 40 companies that we’ve worked with in Europe and the US. In the afternoon following the Masterclass, we’re offering private consultation sessions where you can get personalised advice on your specific RBM, R2 compliance, protocol risk assessments and change management challenges.
Please click here to book your place as spaces are limited.