ABSTRACT
Risk management is a systematic process of identifying, assessing and controlling risks, and communicating the outcomes to all stakeholders in a timely manner. Risk management principles have been effectively utilized in many areas of business and government to facilitate decision-making in the face of risks and uncertainty. Although utilization of such strategies is commonplace in finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries, it was not until the publication of several ICH documents (ICH Q8, ICH Q9, and ICH Q10) at the turn of 2000 did the pharmaceutical industry start adopting the method. Successful utilization of risk management principles has led to development of highly efficacious biopharmaceuticals and robust manufacturing processes (Rathore and Mhatre (2011)). As outlined in ICH Q9, risk management has several key components, including risk assessment, control, and communication. A typical risk management process is shown in Figure 5.1.
