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The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…
Abstract Human medicine has recently seen a move away from the paternalistic patient-physician paradigm course to a collaborative one, where “shared decision-making” is a core principle. No longer a passive bystander, where their case management is…
Human-centred “soft” skills are becoming increasingly essential, especially in the current digital workspace. As medical writers navigate the intricate landscape of compliance and precision, they must fortify their soft skills with a foundation of…
Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…
Every professional needs to develop a set of hard skills and soft skills to grow and prosper in a designated field, and freelance medical writers are no exception. However, freelancing requires a unique combination of skills, given the independence…
The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
Lay summaries are critical for building publictrust in clinical research and therefore forrecruiting patients. They are also an importantpart of efforts to improve data transparency.Due to new global regulations, lay summarieswill soon probably…
A complete re-evaluation of your career path can be a daunting task. By identifying your own key skills, a proactive approach can be taken. Talking to varied companies and people in the field and trying out different writing styles can help to find…
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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Victoria White
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Alicia Brooks Waltman
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AI/Automation
Biotechnology
Digital Communication
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Gained in Translation
Getting Your Foot in the Door
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Medical Communications/Writing for Patients
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My First Medical Writing
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Regulatory Matters
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Teaching Medical Writing
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
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Chris Monk