GlaxoSmithKline Consumer Healthcare on the Path to World-Class Product Safety Surveillance

Abstract

Pharmacovigilance is facing expanding challenges from both the pharmaceutical business and the regulatory agencies, which impact all global pharmaceutical organisations. In the consumer healthcare setting, world-wide sales, regulatory expectations and public awareness of product issues are all increasing. The challenge of maintaining both high-quality adverse event reporting and regulatory compliance in the face of capacity constraints and the evolving safety environment is real. In this context, the pharmacovigilance organisation of GlaxoSmithKline (GSK) Consumer Healthcare redesigned their global processes to world-class standards and implemented industry best practices in order to achieve substantial growth in productivity while maintaining regulatory and corporate compliance. In a year-long initiative, GSK Consumer Healthcare Product Safety has achieved a 70% reduction in adverse event handling process complexity and a 30% increase in productivity; global organisational and process consistency have also significantly improved. GSK Consumer Healthcare Product Safety has also implemented a managerial decision-making system that generates a wide range of rigorous key performance measures. This system allows management to stay continually informed of the global safety operation and initiate proactive, specific improvements or corrective actions based on reliable and up-to-date data. With all these initiatives, GSK Consumer Healthcare Product Safety has placed itself among the best organisations in the industry and on the clear path of continuous improvement.