A Quality Management System for Pharmacovigilance Activities

Abstract

Pharmacovigilance is an area of drug development that is increasingly found in the regulatory spotlight. As a result, companies need to have confidence in the quality and the accuracy of the data being used in the benefit-risk assessments of their products. Roche Products and Novartis have both introduced quality management systems into their pharmacovigilance operations. This paper discusses why such functions are considered necessary and the activities they carry out.