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21世纪监管出版
How AI will significantly cut turnaround in the regulatory publishing workflow
2020年3月12日
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Introduction

几十年来,监管出版一直由手动任务主导。出版商花费数小时格式化文档,生成符合代理机构的PDF文档,进行质量检查,编译文档以提交提交和故障排除问题,以确保已解决所有提交要求并满足截止日期。

These tasks are laborious and exacting, requiring the efforts of professionals with advanced science and medical knowledge to ensure accuracy and integrity of the components and compilation of the submission. For example, on a 200-page summary document in a New Drug Application dossier, a team may spend hundreds of hours to author, review, create summary document links to pages in other documents, and corroborate every statement. This translates to an expensive and time-consuming set of activities that require laser-sharp
focus from the people ensuring basic data searching and verification tasks.

但是,想象一下,如果许多任务都是自动化的。In the not-too-distant future, authors’ and publishers’ jobs will be transformed by artificial intelligence (AI) and machine learning (ML), with algorithms custom-built to manage all the routine work, freeing up skilled professionals to focus on the high-value tasks that leverage their scientific expertise. We aren’t there yet, but innovations in this space are moving rapidly in that direction.

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