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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…
The purpose of paragraphing is to make text understandable and easy to read, and to help you tell your story effectively. Paragraphing is difficult because the purpose of the documents we produce and their readership are diverse. To make matters…
Professional medical writers have an important role in facilitating the accurate and timely dissemination of medical and scientific data. This support should be appropriately acknowledged in peer-reviewed publications, but guidance on how to…
Amidst the dynamic landscape of pharma - covigilance legislation, medical writers have been gaining increased visibility and importance beyond what had been their traditional role of coordinating and facil it - ating the development of risk…
Our mentors It is my great pleasure to introduce this article written by Julia Bates from Australia, who in a very personal way describes her journey to becoming a very professional and experienced medical writer – a journey that often went across…
This article describes the development and use of quality patient decision aids to support patient involvement in making healthcare decisions. Briefly, patient decision aids should provide at least information on options, benefits, and harms, and…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
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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