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Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…
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…
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…
For science to be understood, assimilated, and further developed, it must be accessible through clear and concise writing. Science is about solving problems that often interlink with each other. To improve the clarity of scientific writing, every…
Editorial Welcome to the Translation Section editorial! What we call ‘lay-friendliness’ is a key characteristic of Patient Information Sheets (PIS), which are tightly regulated on a European level to guarantee a comprehensible document that…
In Strategic Scientific and Medical Writing: The Road to Success, Pieter Joubert and Silvia Rogers describe how to identify the target audience, construct key messages, and recognise the desired outcome of your document to make your writing more…
On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…
Abstract The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when…
Microediting aims to ensure consistency aswell as accuracy within a document and across a document series. Also known as technical editing or mechanical editing, it is an important stage in editing, needed to gain and retain a reader’s interest and…
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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