Alert and on guard
Over the past decade, a series of adverse drug safety-related events have led to increased scrutiny and drug safety monitoring regulations. Considering the current environment, the business case for building strong, efficient pharmacovigilance organizations has never been better. Streamlining the global delivery model and improving compliance capabilities will enable pharmaceutical companies to manage risk, achieve operational savings, and minimize avoidable litigation costs.
An effective PV organization must adapt to regulatory changes and address the ever-evolving challenges posed by the modern pharmaceutical environment. There is no “one size fits all” model for PV operations --the right model depends on a company's product mix, global reach, resources and existing capabilities as well as on the company's overall strategy for pharmacovigilance.
The global reach, heightened regulatory scrutiny, and new market factors add up to changes so significant that a new approach toward PV is necessary. The PV model must be rebuilt, starting with setting strategy, developing a plan to build capabilities, establishing a network, and implementing a strong governance structure to maintain these components across a globally-distributed model. The good news is that this global PV delivery model can both streamline operations and improve the value of the PV being delivered. By approaching PV strategically, and taking a measured, long-term approach to developing PV capabilities and building capacity, pharmaceutical companies can begin to focus resources on more valuable, forward-looking activities.