Degree Programs and Certificate
Program Overview
Accelerating discoveries in molecular biology and genetics are energizing the development of new and improved pharmaceutical processes, products, and therapeutic agents. As companies work to turn the process of developing new medicines from an art to a well-understood science, there is also a growing opportunity for individuals with regulatory science expertise.
The pharmaceutical, biotechnology, medical device, and other health-related industries are among the most regulated to ensure product safety and efficacy. With the exception of small discovery companies engaged only in research, each must have experts devoted to regulatory and legal issues. The primary function of these regulatory professionals is to serve as the direct link between the company and various global regulatory agencies such as the US Food and Drug Administration (FDA). They must understand and execute an extensive list of laws, regulations, guidelines, and guidance from regulatory agencies. They must also interact within the company, communicate with other departments within the company, and understand the organization, procedures, and technical operations so that the entire organization can successfully fulfill regulatory and legal responsibilities.
The new regulatory professionals must possess a scientific background with additional statistical and quality training. Knowledge of current concepts such as various Good Regulatory Practices (GxPs) and the International Conference on Harmonization (ICH) are part of their education and training.
We need scientists, bioengineers, and managers who can function in this new global science and risk-based regulatory environment who have comprehensive knowledge of regulatory affairs, dosage formulation, and clinical issues as well as skills such as scientific computing, database and information management, and automation. They are essential to carry out effective work functions for the drug design, pre-clinical, and clinical development of various traditional pharmaceuticals and new biologics as well as novel biomedical devices and combination products