Track: Project Management

Abstract

As global healthcare has faced tremendous focus on the drug development process during the pandemic. During the pandemic, efforts were made to develop drug in couple of months, but every drug development process is bounded by risks. The drug development process tends to be lengthy and exhaustive process. Viewpoint of project management can assist in making the process rational with key milestones. Project risk management is one of the key areas of project, which focuses on quality and risk of project or process. This paper focuses on identifying and mitigating the risks encountered in the drug development process using the quality risk management framework and House of Risk (HOR) Analysis/Method. The study investigates the mitigation of the risks using the appropriate mitigation strategy. The House of Risk (HOR) model involves risk identification and risk mitigation. It enables to identify the risk at each step and mitigate them. The house of risk method ranks the risks and sets the appropriate priority for each of the risks encountered in the drug development process. After identifying the risk, the second phase of the house of risk method is to find the alternatives which can assist in mitigating the risks and consequently ranking them priority-wise. The results show that mitigation strategies determined in the study will enhance the drug development process.