Clinical Trials

Biography

Biography: Lee Truax-Bellows

Abstract

The latest emphasis from regulatory authorities within clinical study conduct is to design, develop and execute clinical studies using a Quality System Approach. While both the FDA and EU emphasize this approach, regulatory agencies provide little direction on how this can be achieved. The latest example of such an approach can be found within the FDA’s guidance on conducting a risk-based approach to monitoring. Risk management is an integral component of a quality system approach. As with a Quality System Approach many researchers do not have the knowledge or experience to conduct clinical trial risk management. This workshop will apply practical approaches and demonstrate associated tools and skills, to assist the participant in using a Quality System Approach within the clinical trial arena.