Date of Award


Degree Type


Degree Name

Doctor of Philosophy (PhD)



Committee Chair

Kari Clase

Committee Member 1

Stephen Byrn

Committee Member 2

James Mohler

Committee Member 3

Geanie Umberger


Role-playing simulations have been effective techniques to encourage global skills in the engineering and design classrooms. May, Wold and Moore (2014), defined global skills as student display of respect, recognition, adjustment and integration. Gray, Debs, Exter, and Krause (2016), took this one step further and looked-for empathy in the design classroom. This has yet to be realized in the regulatory science education realm. Therefore, there is a need for on-line, interactive regulatory science education focusing on global skill outcomes. To assess the gap, four sets of data are collected. The first set was a review of evaluations from a regulatory science course teaching documents and dialogues necessary for drug and device approvals. The evaluations stated that more global skills, problem-solving and innovation needed to be a part of the curricula. The course was reformatted and an interactive simulation called the BIRS Experience included. The second data set came from the student’s final assignments after the BIRS Experience was delivered. The assignments were analyzed for global skills and creative inquiry movements. The students participating in the BIRS Experience were both from the United States and Tanzania. Both sets of participants again answered questions after a regulatory intelligence workshop. This was the third data set. The comments from the questionnaire were analyzed for global skills and creative inquiry movements. The fourth data set was answers to a world café experience delivered at a quality and regulatory affairs summit. In this case, the participants were working professionals asked what competencies were needed for the regulatory science discipline moving forward, again, comments were analyzed for global skills and creative inquiry movements. The theme of needing both global skills and creative inquiry movements was consistent in all four data sets.