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Administering A U.S. Based M.S. Degree in Kilimanjaro, Africa – A Global Benchmarking in Regulatory Science

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Conference

2016 ASEE International Forum

Location

New Orleans, Louisiana

Publication Date

June 25, 2016

Start Date

June 25, 2016

End Date

June 25, 2016

Conference Session

Concurrent Paper Tracks Session I Curriculum

Tagged Topic

International Forum

Page Count

10

Permanent URL

https://peer.asee.org/27230

Download Count

17

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Paper Authors

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Mitchell L Springer PMP, SPHR Purdue University, West Lafayette

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Dr. Mitchell L. Springer, PMP, SPHR

Dr. Springer currently serves as the Executive Director for Purdue University’s Polytechnic Institute located in West Lafayette, Indiana. He has over 35 years of theoretical and industry-based practical experience from four disciplines: Software Engineering, Systems Engineering, Program Management and Human Resources. Dr. Springer possesses a significant strength in pattern recognition, analyzing and improving organizational systems. He is internationally recognized, has contributed to scholarship more than 150 articles, presentations, books and reviews on software development methodologies, management, organizational change, and program management. Dr. Springer sits on many university and community boards and advisory committees. He is the recipient of numerous awards and recognitions; most recently he was awarded the Purdue University, College of Technology, Equity, Inclusion and Advocacy Award.

Dr. Springer received his Bachelor of Science in Computer Science from Purdue University, his MBA and Doctorate in Adult and Community Education with a Cognate in Executive Development from Ball State University. He is certified as a Project Management Professional (PMP), Senior Professional in Human Resources (SPHR & SHRM-SCP), in Alternate Dispute Resolution (ADR), and, in civil and domestic mediation. He is a State of Indiana Registered domestic mediator.

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Kari L. Clase Purdue University, West Lafayette

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Kari Clase is an Associate Professor in the Department of Technology Leadership and Innovation in the Polytechnic Institute and the Department of Agricultural and Biological Engineering in the College of Agriculture at Purdue University. Dr. Clase is also the Director of the Biotechnology Innovation and Regulatory Science (BIRS) Center. The mission of the BIRS Center is to develop global programs to ensure sustainable access to medicines for Africa and developing nations, and to advance discovery in manufacturing technology, quality of medicines, and rare disease research. This mission is accomplished through innovative knowledge-based programs in STEM areas with an emphasis on interdisciplinary collaboration. Dr. Clase teaches multiple courses covering topics in biotechnology, bioinformatics, biological design and drug discovery to engineers, scientists and technologists. Her currently funded projects include collaborators from multiple disciplines and an impact that spans K-12 to graduate education.

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Lauren Ann Terruso Purdue University

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Lauren Terruso is the Operations Manager of the Biotechnology Innovation and Regulatory Science Center in Discovery Park at Purdue University.

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Abstract

Administering a U.S. Based M.S. Degree in Kilimanjaro, Africa – A Global Benchmarking in Regulatory Science

In the world of pharmaceuticals, regulatory science is an emerging field that has goals of developing tools, drugs, devices, and practices to increase benefit and lower risk concerning safety, quality control, and effectiveness. The dangers of having a sub-par, or non-existent, regulatory science practice can be costly at best, or lethal at worst. Formal education at the graduate level to train professionals is a relatively new field. Research has been done on the practice of regulatory science, but not on the institutions educating these scientists. Purdue’s investment, in particular, has the ultimate goal of getting sustainable medicine to Africa. The collaboration of Purdue’s Biotechnology Innovation and Regulatory Science program with the Kilimanjaro School of Medicine is helping to provide good regulatory practices in Africa. This prompted the need to perform benchmarking activities comparing and contrasting the Purdue program to both domestic and international certifications and degrees. The methodology employed to assess the potential list of resources was to make an exhaustive list (as possible, since higher education is constantly changing) of graduate and post-baccalaureate institutions that provide certification in regulatory science fields. First, the categories of cost, availability, and curriculum needed streamlining for comparison purposes. Then, best practices needed to be identified, for both domestic and international programs. Common themes of coursework in the life sciences, biotechnology, and policy/ethics were identified. Often, programs would require or prefer a bachelors in health science, life sciences, or engineering with common requirements of the advanced degree mandating courses in tissue engineering, stem cell engineering and related disciplines. The international programs focused more on global processes than domestic ones. In addition, there was a common trend, both domestically and internationally, that pharmaceutical sciences background/employment experience was preferred and the programs were designed to be part-time so the degree/certification could be earned while remaining employed (some even requiring a project to be completed at student’s place of employment). The most typical degree earned in this field was a Master’s degree and while ranging in cost from $23,000 - $100,000 in the domestic programs, the cost was typically much less expensive in the international programs.

Springer, M. L., & Clase, K. L., & Terruso, L. A. (2016, June), Administering A U.S. Based M.S. Degree in Kilimanjaro, Africa – A Global Benchmarking in Regulatory Science Paper presented at 2016 ASEE International Forum, New Orleans, Louisiana. https://peer.asee.org/27230

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