Master of Science in Global Clinical and Pharmacovigilance Regulations

The M.S. in Global Clinical and Pharmacovigilance Regulations addresses the career needs of individuals involved in domestic and global clinical trials and pharmacovigilance activities within the pharmaceutical industry, including managing and assisting in clinical trials, supervising record keeping of clinical trials, reviewing safety data of clinical trials or post-marketing reports of healthcare products, and other related activities. In recent years, pharmacovigilance activities have been conducted alongside clinical trials to determine the benefits and risk factors of products both under development and on the market. Pharmacovigilance, or drug safety, relates to the myriad of activities the pharmaceutical and related industries use in monitoring, assessing, and compiling the benefits and risks involved with their products. Whereas pharmacovigilance studies used to be undertaken once products were already on the market, the latest trend is to conduct these studies with first in human studies, which are generally done on healthy volunteer subjects to ascertain how a new product affects an individual without the known disease state. Clinical trials are highly regulated research studies of pharmaceutical and related products, treatment options, or medical devices in human beings. Their goal is to find new or better ways to prevent, detect, diagnose, or treat disease or disease states. In order to accomplish this, clinical trials must rigorously follow certain protocols, study designs, and data collection and monitoring methods defined by regulatory authorities.

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