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Leveraging standardised data in response to the novel coronavirus outbreak - Volume 29, Issue

As we are confronted by a new global health epidemic in the form of COVID-19, the challenges and opportunities of global data sharing come into sharp focus. Due to significant data collection and sharing issues during the 2013–2016 Ebola outbreak,…

A history of EMWA - Volume 27, Issue

EMWA has now been in existence for 25 years! How is that possible? Time has flown by, and brought with it much change and growth of which we should be proud. This is an oppor tunity to reflect back on the organisation as it was at its genesis, is…

How can we maximise patient engagement with Plain Language Summary of Publication articles (PLSPs)? A publisher’s perspective - Volume 33, Issue

Plain Language Summary of Publication articles (PLSPs) are aimed at non-specialist audiences, using non-technical/jargon-free and easy to understand language to provide summaries of publications. The introduction of PLSPs has added to the growing…

Statistical principles in biosimilar development - Volume 28, Issue

Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…

Layperson materials in the sphere of biosimilars and generic medicines - Volume 28, Issue

Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…

A medical writer's must-have software - Volume 23, Issue

This article provides a list of software useful to medical writers according to the booklet ‘The WRITE tool for the job’ compiled by Emma Hitt. Software categories include: word processors; reference managers; PDF readers; project planning and…

In the Bookstores - Volume 22, Issue

This book is regarded by many as the holy grail of reference manuals. For those not familiar with the great tome it contains a massive amount of information regarding ‘publication style and format for scientific papers, journal articles, books, and…

Social Media: A tool that can benefit public health? - Volume 29, Issue

The global use of social media has changed access to health information, and the internet has become its primary source for the general public. However, judging health information on social networks remains difficult for nonmedical readers since…

Regulatory Public Disclosure - Volume 30, Issue

Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

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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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