Author: Dr. Chitra Lele, Sciformix Corporation
Greater public awareness of drug safety issues and emerging informatics-based methods for acquiring and analyzing medical information, have sparked global initiatives to transform the current largely reactive safety system into one that is proactive, robust, and more useful clinically (1, 2). In addition, the emerging importance of patient centricity and increase in publically available safety data are also driving this change (3). Thus, the need for proactive pharmacovigilance or productvigilance (PV) is being increasingly acknowledged by all companies, regardless of their size and product mix.
Regulatory expectations around the safety and risk management of products have undergone a period of extensive change, with regulations in developed regions becoming more stringent and regulations in emerging markets evolving rapidly. The growing importance of 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, thereby making PV operations increasingly complex. Other factors contributing to this complexity are the shift in the mix of small and large molecules and therapeutic area focus, and the rigor required to capture safety data for newer classes of products.
Therefore, while diverse regulations and guidelines govern PV practices, it is also critical to ensure that all safety systems and PV practices employed by an organization firmly tie into a unified and truly global PV framework, which is an important pre-requisite of proactive PV. Establishing such a framework takes a lot more than simply capturing safety data from affiliates, partners and distributors. This article will look to explain the what, why and how of a global PV system and set out how to establish the global PV strategy.