The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of enhancing patient care and safety.1 While the goal of pharmacovigilance remains constant, the methods, resources, and regulations that are designed to reach this goal are continuously being updated and optimized. Adding to this inherent complexity, pharmacovigilance also involves the coordinated interaction of multiple players, including patients, healthcare professionals, pharmaceutical companies, and multiple regulatory authorities across various regions.
Over time, the pharmacovigilance process has become more proactive in the monitoring, assessment, and reporting of drug-related adverse events. In addition, the pharmaceutical industry itself has also gone through a period of transition, in which the concept of the fully integrated pharmaceutical company was challenged by a variety of factors, including increasing economical and productivity pressures, expansion of the generic marketplace, and globalization of manufacturing and clinical research. Pharmaceutical companies operating as completely virtual enterprises are also entering this arena. As such, specialized contract organizations have become partners to pharmaceutical companies in order to supplement their core service offerings, including the outsourcing of manufacturing, clinical trial execution, and, in the case of virtual companies, any activity that requires physical assets or infrastructure. More recently, the clinical and regulatory expertise of contract research organizations (CRO) has also been utilized by pharmaceutical companies for the initiation and implementation of pharmacovigilance processes and procedures throughout the lifecycle of their products.
Over time, the pharmacovigilance process has become more proactive in the monitoring, assessment, and reporting of drug-related adverse events. In addition, the pharmaceutical industry itself has also gone through a period of transition, in which the concept of the fully integrated pharmaceutical company was challenged by a variety of factors, including increasing economical and productivity pressures, expansion of the generic marketplace, and globalization of manufacturing and clinical research. Pharmaceutical companies operating as completely virtual enterprises are also entering this arena. As such, specialized contract organizations have become partners to pharmaceutical companies in order to supplement their core service offerings, including the outsourcing of manufacturing, clinical trial execution, and, in the case of virtual companies, any activity that requires physical assets or infrastructure. More recently, the clinical and regulatory expertise of contract research organizations (CRO) has also been utilized by pharmaceutical companies for the initiation and implementation of pharmacovigilance processes and procedures throughout the lifecycle of their products.