Brian Edwards

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Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the(More)
Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental(More)
Society has been increasingly intolerant of excuses for systems breakdown in many areas of public life. This is hardly surprising given that there is overwhelming evidence behind why processes fail and mistakes are made, and so, based on this evidence, processes should be designed to mitigate risk. The main root cause of many process failures can be(More)
Clinical research is at a cross-roads of sustainability due to the current cost of development, amount of regulation, and irrational use of medicine. There are also too many silos in clinical research and development, post-marketing safety, as well as a lack of standards, and effective communication. This paper covers the future of pharmacovigilance and(More)
Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product(More)