Event Date/Time: Jun 04, 2012
End Date/Time: Jun 05, 2012
Barnett International and Cambridge Healthtech Instituteâ€™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 sponsorsâ€™ quality systems in clinical research, and of the shifting expectations for sponsorsâ€™ 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.