Clinical Quality Risk Management

Barnett International and Cambridge Healthtech Institute’s Inaugural Clinical Quality Risk Management conference will focus on meeting the emerging regulatory expectations for a quality systems-based approach to GCP compliance. FDA compliance officials are increasingly speaking about the importance of sponsors’ quality systems in clinical research, and of the shifting expectations for sponsors’ clinical trial oversight, in particular to a quality risk management approach in trial oversight. European regulators have also expressed interest in the topic, and are reportedly working on a risk-based quality management approach for clinical trial conduct and supervision. Thought leaders will share their experiences implementing clinical QRM, creating quality systems-based approaches to clinical monitoring and auditing that produces reliable data, and responding to the evolving regulatory landscape.