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News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…

Oncology and medical writers - Volume 21, Issue

Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that is…

Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare - Volume 23, Issue

Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…

Regulatory Matters - Volume 28, Issue

Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…

Teaching Medical Writing - Volume 28, Issue

The training of medical writers is not to be taken lightly and requires serious input from industry, established medical writers, and the academics making the transition. Following on from previous articles in Medical Writing, Sarah and Adrian Tilly…

Mentorship from the inside - Volume 30, Issue

In this article we interview Jose Francisco Sanchez Herrero from the Germán Trias i Pujol Institute in Badalona. He is Selma’s tutor and gives us a glimpse of what it is like to be a mentor in an academic setting. If there is one thing we learned…

In the Bookstores - Volume 26, Issue

A research paper is often the culmination of years’ worth of data and experiments, successes and failures, doubts and triumphs, as well as a balancing act between many different opinions from different authors. Writing one can be a daunting task,…

Editorial - Volume 29, Issue

When we first sent out the call for papers for the Autumn 2020 issue of Medical Writing, there were only a few reports of a novel coronavirus. Today, of course, COVID-19 is a pandemic. Welcome to the “new normal” , where many of the routines,…

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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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