Abstract
The author, an experienced freelance regulatory writer for the pharmaceutical industry, describes her experience contributing to the redesign and teaching of a distance learning graduate course titled Medical Writing for Clinical Research at George Washington University (Washington, DC). This course analyzes and evaluates major clinical research-related regulatory documents that contribute to product development.
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Wood LF, Foote M. eds. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologies. Basel: Birkhäuser Verlag: 2009.
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Bowen, S. Enhancing the Clinical Professional’s Knowledge of Regulatory Documents. Ther Innov Regul Sci 45, 151–154 (2011). https://doi.org/10.1177/009286151104500209
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DOI: https://doi.org/10.1177/009286151104500209