ABSTRACT
The evolution of safety evaluation practices has been guided in large part by advances in methods promulgated by expert working groups, such as the Council for International Organizations of Medical Sciences, the International Council for Harmonization and guidances and regulations from health authorities. In order to perform a comprehensive analysis of aggregate safety data, professionals from a variety of disciplines are required, including only safety clinicians but also data managers, biostatisticians and programmers. The safety specification is created from a comprehensive review of non-clinical and clinical experience as well as a consideration of the epidemiology of medical outcomes in the population under study and the safety profile in vulnerable populations such as the young, the elderly and those with various organ insufficiencies. The use of aggregate assessment of safety data was further conveyed in the FDA guidance on pre-market risk assessment.
