Dr. Chitra Lele, Sciformix Corporation
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, 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.
Another factor adding to the complexity is the shift in the mix of small and large molecules as well as the therapeutic area focus, and the rigour required to capture safety experience 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 organisation firmly tie into a unified and truly global PV framework, which is an important pre-requisite of proactive PV. Establishing such a framework involves a
lot more than simply capturing safety data from affiliates, partners and distributors.
- Kahn, S. (2013). ‘Proactive pharmacovigilance – A new model for the 21st century.’ International Pharmaceutical Industry, 5(3), pp. 62–66
- Moe Alsumidaie, 2014. ‘Highlights from the 2014 Patient Centered Clinical Trials Symposium.’ Applied Clinical Trials. Online at www.appliedclinicaltrialsonline.com/highlights- 2014-patient-centered-clinical-trials-symposium [Accessed 06/02/2015]