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Clinical data publication by the EMA: The challenges facing the pharmaceutical industry - Volume 27, Issue

As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised…

Out on Our Own - Volume 26, Issue

As a part of its initiative in forging alliances with associations that promote freelancing at a national level in Europe, EMWA has recently tied up with the Verband der Gründer und Selbständigen Deutschland e.V. (VGSD) which is based in Germany.…

News from the EMA - Volume 30, Issue

Medical writers at EMA have published an “EMA medical terms simplifier” (https://www.ema.europa.eu/en/documents/ot her/ema-medical-terms-simplifier_ en.pdf) on the “Glossaries” page of EMA’s website (under “About us”) to provide public-friendly…

Message from the President - Volume 21, Issue

Dear Medical Writers Top of Form Bottom of Form The last time I wrote to you I briefly introduced myself and outlined some of the plans that I hope to realise during my year as president. However, as president I am only one of the members of the…

Out On Our Own - Volume 25, Issue

The theme for the FBF at the Munich conference was Out On Our Own but Not Alone. With an impressive attendance by more than 60 freelancers (FLs) from Europe and beyond, and also a special guest – Dr Andreas Lutz of the VGSD, a German association…

Out On Our Own - Volume 22, Issue

Editorial We hope that you enjoyed the summer months and found time to step away from your desks and relax. This time last year, Kath organised her first ‘Medical Writers’ Retreat’, the aim of which was to provide an opportunity for fellow…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…

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.…

Manuscript Writing - Volume 22, Issue

As a medical writer, can or should I be listed as an author of an article? For manuscripts, medical writers often go far beyond providing basic services and therefore may feel entitled to authorship. Medical writers are often the main force behind…

Letter from the Editor - Volume 25, Issue

A step – no a leap – forward In 2012, the journal’s precursor, The Write Stuff, became Medical Writing under the guidance of then Editor-in-Chief Elise Langdon-Neuner. The Write Stuff had been managed almost single-handedly by Elise, and the shift…

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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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