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Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
The United Nations Sustainable Development Goals (SDG) call all UN member states– low-, high- and middle-income – to promote prosperity while protecting the environment. The 17 goals are part “of a shared blueprint for peace and prosperity for…
Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…
The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…
Since 2014, I have offered a four-day course on academic writing for qualitative health researchers at the University of Southern Denmark. I tell the participants, mostly PhD students with backgrounds in the health professions, that “learning to…
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…
Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…
As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…
Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
Medical Writing is listed in the following indexes:
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Alicia Brooks Waltman
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