Brian Edwards, NDA Regulatory Science Ltd
In December 2013, there was a major breakthrough with the publication of the Human Factors Concordat by the UK government. This has been primarily aimed at patient Safety within the NHS. The pharmaceutical system was not included. For that reason, we have established a pharmaceutical Human factors & Ergonomics group within the CIEHF with the aim to promote debate and develop programmes of work that include the capacity and capability of HFE and identify what support is needed to enable pharmaceutical organisations of all forms and sizes to embed HFE principles and practices into their culture, systems and processes.
This unique group is open to all who work in the pharmaceutical sector at any level and in any discipline who are committed to enhancing human performance towards greater safety and efficiency. Our vision is of a pharmaceutical system that places an understanding of HFE at the heart of improving clinical, managerial and organisational practice leading to significant improvements in the way researchers and organisations manage and supervise the ongoing conduct of clinical research and the safe use of medicines throughout the life cycle. Ultimately this would provide more effective assurance to regulatory and governance reviewers that research and marketing activities are being conducted well to produce high quality reproducible data and evidence ultimately leading to improved clinical safety and decision-making, communication and tackling unnecessary bureaucracy. In other words, this is central to effective quality management.