The Arizona State University College of Nursing and Health Innovation has been selected by the Food and Drug Administration, Center for Drug Evaluation and Research (CDER), as the educational site for the Centers Academic Collaboration Program (CACP). This partnership will prepare professionals for careers in regulatory science and health safety and is the first academic partnership that the FDA has formed with a college of nursing and health in the nation.

The academic partnership has enabled the launch of the Master of Regulatory Science and Health Safety (RSHS) degree, starting in fall semester 2010.

The United States and global bioscience research and medical products industries increasingly require individuals with graduate level degrees who can conduct business in accordance with regulatory requirements. As the result of the explosion of new products every year and increased scrutiny of health products throughout their lifecycle, line staff and managers who can interpret the regulations, verify that they were followed, evaluate research data, and assure the safety and effectiveness of new products  are needed to protect the public health.

The largest employment need is for clinical research managers, auditors, inspectors and regulatory oversight personnel. This degree program provides the credentials to serve as an entry- or mid-level associate in a broad range of regulatory affairs positions.

“We are excited about this innovative partnership with the FDA and are looking forward to educating the next generation of professionals with the necessary knowledge and skills to ensure that new drugs and health products meet the highest quality and safety standards,” said Bernadette Melnyk, dean of the college.

“Working collaboratively with academia, industry and other partners is key in advancing regulatory science,” said Capt. Greg Wood, director of the CDER Academic Collaboration Program. “In the development of the Master of Science in Regulatory Science and Health Safety program curriculum, we were pleased that input from the FDA/CDER/CACP was strongly considered and incorporated by ASU and the college. This program will provide valuable knowledge and experience in preparing students to work in settings such as the FDA, regulated industry and beyond.”

Program Overview

The Master of Science in Regulatory Science and Health Safety (RSHS) degree is designed as a full-time in-classroom degree that will be completed over two years. The purpose of the MS degree is to prepare students for careers in the field of Regulatory Affairs with an emphasis on safety, risk management, partnership development and leadership. The program also builds and strengthens communication skills such as creating, delivering and defending presentations and learning regulatory writing techniques.

 

Core courses for the new RSHS program are primarily offered by ASU College of Nursing and Health Innovation, including courses from the Master of Healthcare Innovation and Master of Clinical Research Management program. Other courses are housed in the Sandra Day OConnor College of Law and the Ira A. Fulton Schools of Engineering. FDA/CDER staff will serve as adjunct faculty and special guest speakers for the program. Dr. Sandra Shire, a dentist and former FDA employee, has been named as the programs first director.

The RSHS degree uses a multidisciplinary approach to meet the needs of regulating bodies and the regulated industry. It encompasses coursework in clinical research, ethics, quality systems, quantitative methods and statistics, leadership, and project management in the regulatory field.

The transdisciplinary program is designed for scientists, nurses, physicians, pharmacists, and other health and quality assurance professionals, among others, who want to work in or advance their career in Regulatory Science.

The FDA/CDER Academic Collaboration Program is fully funding up to 10 students, or half of the first cohort, which starts fall semester in August 2010. Students selected for this program will be full-time students at ASU as well as active duty officers in the Commissioned Corps of the U.S. Public Health Service. Those selected will receive tuition, housing allowance, and a competitive salary with active duty benefits while in training. In return, the Academic Collaboration students must agree to work for FDA/CDER for two years for each year of paid tuition as a Commissioned Corps officer. The program also will recruit non FDA-funded students who may seek employment with a regulatory agency or with regulated industry upon completion of the degree.

 

The College of Nursing and Health Innovation is listed in the top 8 percent of graduate colleges of nursing in the nation according to current U.S. News & World Report Rankings. It takes an integrated approach to education and includes nursing, nutrition as well as exercise and wellness programs in addition to innovative healthcare offerings.

Editorial Source:

Sandra Shire, Sandra.Shire@asu.edu, (602) 496-1694

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