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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…
Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
What if everything you read was up to 30% shorter and more easily understood? What if everything you wrote was up to 30% shorter and more easily understood? Would that be a skill worth developing? Would your employer or clients notice if your work…
Dear all, A very warm welcome to the first issue of Medical Writing in 2015! This whole issue is dedicated to a subject very close to my heart (as I'm sure you're all well aware of by now) – plain language. Naturally, everyone benefits from text…
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,…
In October 2016, EMWA’s Executive Committee sent an on-line survey to all EMWA members. The purpose of the survey was to obtain more information about our members, what they do, and what they want from the organisation. 286 responses were received.…
In the December 2014 issue of Medical Writing, I reported that disgraced Iowa State University researcher Dong-Pyou Han was facing fraud charges for faking experiments on a new HIV vaccine.1 In spite of a guilty plea, on 1 July 2015 Dr Han was…
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…
Before one can get one’s foot in the door, one needs to be aware that there is actually a doorway. This is the mission of the EMWA Ambassador’s Programme – to inform the world about medical writing as a career path. In other words, we set up signs…
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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