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Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

NICE guidance on health technologies and the role of editors - Volume 22, Issue

The National Institute for Health and Care Excellence (NICE) is the independent organisation in England responsible for developing national guidance, standards, and information on providing high-quality health and social care, and preventing and…

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

Letter to the Editor: Because you're worth it? - Volume 23, Issue

To the Editor – I read the recent article on the fourth EMWA freelance business survey1 with great interest and some considerable concern. When freelance writers express an interest in working with Rx Communications, one of the first things we ask…

Journal Watch - Volume 22, Issue

Retracted publications, the issue of poor results reporting, and the increasing value of online teaching methods. Fang et al.1 think that it is important to evaluate scientific publications that have been retracted because they feel studying…

Predatory publishing – what medical communicators need to know - Volume 28, Issue

The rise of ”predatory journals”, also known as pseudo-scientific journals, poses a risk to the integrity of science and therefore medical communicators need to know about their practices. Upon receipt of a publication fee, predatory journals…

Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

EMWA News - Volume 28, Issue

On July 29, EMWA, together with the American Medical Writers Association (AMWA) and the International Society for Medical Publication Professionals (ISMPP), issued a joint position statement on the dangers of predatory publishing (see p. 34 of this…

Lay summaries for Phase 1 trials in healthy volunteers - Volume 29, Issue

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…

Medicinal products and medical devices in clinical trials conduct and disclosure - Volume 28, Issue

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No.…

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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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