Agile Strategies in the Rigid Regulatory Environment
This article will discuss the real-world application of agile project strategies to expedite the development of high-quality deliverables that satisfy the structure and rigor of the regulatory environment. The coronavirus disease 2019 (COVID-19) pandemic challenged regulatory writers not just to rethink the structure of their workdays and the nature of their interactions with their colleagues but to leverage technology and adopt strategic project thinking to help their teams meet aggressive timelines while working in the virtual workspace. Scenarios will include the application of agile project strategies to working on COVID-19 programs or programs heavily impacted by COVID-19, from expedited submission processes to rapid responses to regulatory authority requests for information. This assessment will include what strategies worked well, what strategies did not, and what an agile project should look like within the regulatory writing space.
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