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News from the EMA - Volume 30, Issue

Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…

Regulatory pathways for development and submission activities - Volume 28, Issue

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…

Biosimilar development – an overview - Volume 28, Issue

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…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

Medical Communications - Volume 24, Issue

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…

English Grammar and Style - Volume 21, Issue

Good Writing Practice As an editor, I have been battling against verbosity, redundant modifiers, and ‘buzz’ words for many years. New terms and turns of phrase or new meanings for words pop up all the time. Many of them have come with the…

PhD student: A medical writer in the making! - Volume 27, Issue

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,…

Results of the 2016 EMWA member survey - Volume 26, Issue

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.…

HIV research fraudster handed stiff prison sentence - Volume 24, Issue

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…

In the Bookstores - Volume 28, Issue

They say, “Never judge a book by its cover”. But I do. I pick it up, weigh it in my hands, examine it front and back; sometimes, I even smell it, searching for any hints that will help me divine its worth. From the exterior, Successful Scientific…

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Scope

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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