How pharma companies can develop effective lifecycle-long safety risk management

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 a 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 pressures to bring the safety risk management process of pharmacovigilance (PV) into earlier phases of development, thus making it increasingly business-critical.

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Developing Holistic Safety Risk Management

If you would like further information please contact Kate Adams at kate.adams@wcigroup.com