In recent years, the combination of greater public awareness of drug safety issues and emerging informatics-based methods for acquiring and analysing medical information have sparked global research initiatives to transform our present largely reactive safety system into one that is proactive, robust, and more useful clinically1. In addition, the emerging importance of patient centricity and increase in publicly available safety data are also driving this change2. As a result, the need for proactive pharmacovigilance or ‘productvigilance’ (PV) is being increasingly acknowledged by all companies, irrespective of their size and product mix.
Regulatory expectations around the safety and risk management of products are undergoing a period of extensive change
Regulatory expectations around the safety and risk management of products are undergoing a period of extensive change, with regulations in developed regions becoming more stringent and regulations in emerging markets evolving rapidly. Growing importance of the emerging markets has caused a shift in the geographic focus of the marketplace. This has led to partnerships among multiple stakeholders across the globe, including generics manufacturers, distributors, service providers and technology providers, thus making the PV scenario quite complex.
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