Trends in regulatory writing[26-11-2019]
A brief overview for aspiring medical writers - Surayya Taranum, PhD, Scientific Writer 4ClinicsAbstract
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical writers need to be aware of trends in the regulatory landscape to adapt to new requirements in technical documentation.This article is an overview of the evolving trends in EU regulations for medical devices (Medical Device Regulation and In-Vitro Device Regulation) and data compliance (General Data Protection Regulation and EMA Policy 0070), and the impact of artificial intelligence (AI) on the global medical writing market.
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