The latest update to ICH E6 R2 expects Sponsors and Contract Research Organizations (CROs) to have systems in place to design, conduct, report and oversee their clinical trials with a risk-based approach. This approach means much more than remote and centralized site monitoring. Risk-based Monitoring (RBM) or Quality Risk Management (QRM) must reach into every functional area to ensure compliance and successful outcomes. Does your team have the knowledge and training documentation on QRM concepts and application to GCP to perform new RBM practices? If not, you aren’t alone. This is a new skill set for many Sponsors, CROs, Sites, and IRB/ECs teams within clinical research. This session serves as foundational training that will fit with – and support – any QRM project, and support your team’s confidence to think and perform differently.
This 60-minute course will provide you with the essential information you need in regard to understanding and implementing QRM in clinical trials. Join us to understand the impact of ICH GCP E6 (R2) changes and what it means to implementing QRM in your current efforts.
By attending this interactive live session, you will be able to:
- Define quality risk management and related concepts.
- Apply QRM within clinical trials in accordance with ICH GCP E6 (R2).
- Apply the approaches of quality risk management to the activities of GCP.