Medicine and Health Sciences Commons^™

Solving The Continual Improvement And Innovation Challenge For The Benefit Of Patients: How An Effective Pharmaceutical Quality System (Pqs) And Risk-Based Approach Could Transform Post-Approval Change (Pac) Management, Emabelle Ramnarine

Dissertations

Patients deserve their medicines on time every time. Regulators safeguard public health by ensuring availability of safe, effective, high-quality medicines. Pharmaceutical companies must continually improve and innovate to deliver such medicines. In spite of these patient-centric objectives, drug shortages have continued to grow as a global public health concern. The drug shortage problem has existed for decades though there has been no shortage of effort, recommendations, papers, and expectations to resolve it. During the ongoing COVID-19 pandemic even exceptional measures were rapidly implemented to prevent shortages, yet no long-term solutions have been found.

This research hypothesis was that due to …