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Pronouns are useful referents (i.e. the thing doing the referring) to avoid repetition of words (usually nouns). Although personal pronouns (he, she, and I, in particular) are infrequent in medical writing, the neutral ‘it’ and the demonstrative…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was…
Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…
As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…
The scholarly record is an ever-evolving network – or graph – of truth assertions on which each discipline bases its discussions, and against which each discipline measures its progress. But what if the scholarly record is missing a significant…
Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…
At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy,…
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…
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…
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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