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If a misinformed voice speaks out in the wilderness and no one refutes it, does it make a sound? A call to advocacy - Volume 22, Issue

The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the…

Quality of life measures – an overview - Volume 27, Issue

HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…

The new value of clinical data in Europe - Volume 29, Issue

The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…

In the Bookstores - Volume 24, Issue

Do you know the difference between compliment and complement? Do you know your breeches from your breaches? Do you know why the word ‘Ghoti’ should be pronounced ‘fish’? Answers to these questions and many other interesting facts regarding the…

Regulatory Writing: Review process in regulatory writing - Volume 24, Issue

Recently, Phil Leventhal posed the question ‘What does it take to go from being a good medical writer to an excellent one?’ on EMWA's LinkedIn Discussion Group. My impression is that the responses were written largely with medical communications…

Publication management software for medical writers - Volume 29, Issue

Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…

English Grammar and Style - Volume 22, Issue

We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…

Good Writing Practice - Volume 26, Issue

Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…

Connecting the dots across the writing continuum - Volume 32, Issue

A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…

The role of real-world evidence in post-market clinical follow-up - Volume 34, Issue

Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements, methodologies, and…

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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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