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Legal remedies for medical ghostwriting: Imposing fraud liability on guest authors of ghostwritten articles - Volume 22, Issue

There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical…

Profile: An interview with Dr Gustavo A. Silva on the concept of public health in medical writing and translation - Volume 22, Issue

We often tend to consider the different branches of medical translation as unique islands of knowledge. We may imagine translators specialising in single areas such as oncology, ophthalmology, gynaecology, and so on. Nevertheless, there are indeed…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

Writing in plain language for the Summary of Safety and Clinical Performance: Communicating medical device safety and performance data to patients - Volume 34, Issue

Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

Does standardisation improve animal testing of medical devices? - Volume 26, Issue

Abstract Compliance with European regulatory standards in animal research could be viewed as a way of dotting the i’s and crossing the t’s, rather than actually holding the research to scientific scrutiny. Standardisation is important and needs…

How to combat medical misinformation with a sound content strategy - Volume 28, Issue

In our post-truth era of media and communications, implementing a sound content strategy can help your message reach the right individuals. It is time for experts and healthcare companies to lead the change as ethical and credible sources of…

How to survive Brexit as an independent medical writer - Volume 26, Issue

While Brexit has brought about a period of uncertainty in the UK’s pharmaceutical industry, what is an appropriate response by medical writers at such a time? Few successful businesses stand idle and wait for things to happen. Taking a look at the…

Sound, microphone, action: Podcasts for medical writers - Volume 28, Issue

A podcast is a digital audio file that can be downloaded into your computer or mobile device. It is typically available as a series, and new episodes can be received automatically by subscribers. Podcasts are a source ofeducation, inspiration, and…

Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO - Volume 25, Issue

The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…

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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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