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In this issue, we are bringing to you many updates on different aspects relevant to our medical writing community. Tim Koder from Oxford PharmaGenesis introduces the Open Pharma project, which aims to promote and aid a faster and more transparent…
A wintry London in January saw the release of the first joint position statement on the role ofthe professional medical writer (page 7). But why do we need such a statement and what does it say? The Executive Committee identified the need to update…
We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…
Recently, Phil Leventhal posed the question ‘What does it take to go from being a good medical writer to an excellent one?’ on EMWA's LinkedIn Discussion Group. My impression is that the responses were written largely with medical communications…
Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…
One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…
With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
Help, I can't shorten my abstract! Oh yes you can! (Part 1 of 2) Abstracts are perhaps the most important part of a manuscript because they are often the only part that is read and used as an information source. They are also used by readers…
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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Victoria White
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The Crofter: Sustainable Communications
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