Traditionally the approach to drug safety has been focused on the reactive.  Recent events have shown that this is not enough to ensure visibility of safety risks during clinical development

Life Science companies have public responsibilities beyond those of ordinary business ethics.  Public safety is paramount and, in the context of drug development, it is important to make all reasonable efforts to understand the emerging benefit and risk profile of the product.  This will not only ensure that the patients entering trials are protected, but that the risk of product failure is appropriately managed.  

Recent drug withdrawals and failures to obtain approval have put both industry and regulators under pressure to improve safety surveillance during drug development.  This has led to pressure to bring the safety risk management processes of pharmacovigilance into earlier phases of development, thus, making pharmacovigilance increasingly business critical. 

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Developing Holistic Safety Risk Management.pdf