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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…

The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective - Volume 32, Issue

Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

Gained in Translation - Volume 24, Issue

Editorial Welcome to the Translation Section editorial! What we call ‘lay-friendliness’ is a key characteristic of Patient Information Sheets (PIS), which are tightly regulated on a European level to guarantee a comprehensible document that…

The need for community: The importance of networking as a freelance medical writer - Volume 32, Issue

Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…

EMWA news - Volume 21, Issue

News from the EMWA Website Manager New role At the recent EMWA conference held in Cyprus, I assumed the position of EMWA Website Manager. While this is a daunting task, it is a challenge I am pleased to take on. To ensure that I was in a…

When less is more: Medical writers as guardians of curated content - Volume 28, Issue

In this data-driven era, the type and format of publicly available medical and scientific information is significantly changing. Medical writers can serve as guardians of the information entering the public domain by ensuring accuracy and…

News from the EMA - Volume 30, Issue

Zynteglo is a one-time treatment for a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions. It is a gene therapy that uses a viral vector (or modified virus) to deliver a working gene into…

Foreword from the European Commission - Volume 31, Issue

Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…

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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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