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The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the…
Moving to the virtual space… EMWA’s fall conference was a virtual event, but with a twist – local hubs were established to permit a face-to-face experience for participants in Benelux, France, Germany, Italy, Portugal, Serbia, and Switzerland. In…
Quality assurance (QA) is an important part of the translation process; its ultimate aim is to ensure that a high-quality translation is produced. Traditionally, QA was very much a task undertaken by humans, but recent years have seen the advent of…
This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…
Much has been written about the ethics of medical interpreting, but not so much about purely written translation. What moral principles apply (or should apply) when I translate a document for a client? Do I need to invent these principles myself, or…
Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…
Ensuring population diversity in clinical trials is essential yet challenging and increasingly complex in the rare disease landscape. The unique challenges in clinical development for rare diseases include limited medical and scientific knowledge,…
Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…
With the ever-increasing stock of PhD holders and the diminishing number of permanent academic positions, alternative careers are in demand. Before the impostor syndrome marches in, these graduates need to realise that there can be a bright future,…
The Vienna Conference is done and dusted. But the aftermath is so rewarding, as my knowledge has broadened and my network has widened. It was a joy to meet old colleagues but also get to know many people who are new to medical writing. In this…
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.
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