Regulatory Science Education: The Need for Generalization
Ever since the beginning of regulatory science, the need for relevant education has been recognized. However, after the Food and Drug Administration (FDA) officially recognized regulatory science, several universities have developed educational programs. This paper provides the results of a study to...
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| Veröffentlicht in: | Journal of regulatory science 2020-08, Vol.8, p.1-7 |
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| creator | Moghissi, Alan Calderone, Richard Auffret, Jean Pierre Jaeger, Lisa Longstreth, Janice McBride, Dennis Steen, Tomoko Harrison, David Garrison, Destini McDaniel, Natalie Debrah, Henry Gloutak, Larissa Shumway, Douglas Turner, Deniek Woolley, Griffin Washington, Kerra |
| description | Ever since the beginning of regulatory science, the need for relevant education has been recognized. However, after the Food and Drug Administration (FDA) officially recognized regulatory science, several universities have developed educational programs. This paper provides the results of a study to evaluate the existing education programs on regulatory science. The study identifies the generic definition of regulatory science, consisting of applied version of various scientific disciplines used in the regulatory process. The study found that the educational programs in regulatory science largely dealt with compliance with FDA regulations. In many cases, the programs used the term "regulatory affairs" to describe the regulations and how to comply with them. Based on the experience at Georgetown University, the study provides an outline for regulatory science education. The proposed educational program consists of: 1) approximately 10 topics that are relevant to most, if not all, regulatory science disciplines; 2) a summary of various regulatory science disciplines; and 3) education in specific regulatory science disciplines.
https://doi.org/10.21423/jrs-v08moghissi |
| doi_str_mv | 10.21423/JRS-V08MOGHISSI |
| format | Article |
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| language | eng |
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| source | DOAJ Directory of Open Access Journals |
| title | Regulatory Science Education: The Need for Generalization |
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