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The Investigator's Brochure: A multidisciplinary document - Volume 23, Issue

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…

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…

A picture is worth a thousand words - Volume 29, Issue

As modern medical writers, we face a changing communication landscape greatly altered by the arrival of the internet and the rise of social media. This article provides insights on how to keep pace and what options you have to make your…

Systematic hospital collection of patient-reported outcome data via patient apps - Volume 27, Issue

Medical writers are increasingly likely to come across patient apps in their work, and we describe here the background and use of two apps for assessing patient-reported outcome (PRO). Systematic collection of PRO data via patient apps has been…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

New myths about English - Volume 21, Issue

My first 39 myths about English were published in The Write Stuff in a series of articles between January 2006 and January 2008. The myths are mainly drawn from claims about English made by participants at my training events on the use of English…

Science journalism: In search of a new identity - Volume 26, Issue

Abstract Science journalism is undergoing a major transition due to changes in the relationship between science and society and dissemin - ation via digital and connective technologies, as is the case with other branches of journalism. The changes…

ICMJE requirements for sharing individual participant data from interventional clinical trials - Volume 28, Issue

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…

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…

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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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