General Principles of Pharmacovigilance in Clinical Development

Abstract

Pharmacovigilance is a broad field that spans across all stages of the life cycle from preclinical drug development, clinical development, marketing approval, and post-marketing use. This chapter will focus on the pharmacovigilance aspects of interventional clinical trials. It provides a brief overview over the key elements of protecting patients in clinical trials as well as collecting and reporting safety information for the purposes of developing the safety profile of an investigational medicinal product. Regulations and requirements across the globe are complex and national, while certain international standards through the ICH guidelines form a common basic platform through which multinational clinical trials can harmonize.