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An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…
A research paper is often the culmination of years’ worth of data and experiments, successes and failures, doubts and triumphs, as well as a balancing act between many different opinions from different authors. Writing one can be a daunting task,…
Writing for lay audiences, especially lay summaries, is needed to increase health and science literacy, but this kind of writing can be difficult for scientists. The article describes why it can be so difficult and gives some advice on how…
I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…
Involving patients in decisions about their care attracts wide support in theory, but making it happen in practice has proven quite difficult. Embracing shared decision-making with patients will be more important than ever when healthcare…
Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…
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),…
All of us are aware by now that we can't live without technology and not only at work. With advice, aids, appliances and apps in abundance, we are at the point where we can't see the wood for the trees. Thank goodness we have advice from M…
We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…
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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AI/Automation
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My First Medical Writing
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The Crofter: Sustainable Communications
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