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Medical Devices - Volume 27, Issue

Want to learn more about medical device regulations? Then read some of the presentations held at EMWA’s medical device symposium this year: https://www.emwa.org/conferences/emwa-symposia/.

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…

Lay summaries and writing for patients: Where are we now and where are we going? - Volume 28, Issue

We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…

Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Writing for lay audiences: A challenge for scientists - Volume 24, Issue

Writing for lay audiences, especially lay summaries, is needed to increase health and science literacy, but this kind of writing can be difficult for scientists. The article describes why it can be so difficult and gives some advice on how…

"Processing health-related data for scientific research: Is consent an appropriate legitimate ground?" - Volume 29, Issue

I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…

Patients are decision makers too - Volume 30, Issue

Involving patients in decisions about their care attracts wide support in theory, but making it happen in practice has proven quite difficult. Embracing shared decision-making with patients will be more important than ever when healthcare…

Getting Your Foot in the Door - Volume 25, Issue

Welcome to Getting Your Foot in the Door or GYFD for short, the latest addition to MEW’s regular sections. It all started at the EMWA 2015 autumn meeting in The Hague. Derek Ho met up with the EMWA Executive Committee (EC) to talk about his idea of…

News from the EMA - Volume 23, Issue

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…

Thriving in the data economy as data-fluent PhD graduates - Volume 29, Issue

We are living in an era of data deluge. With the amount of data generated increasing rapidly, organisations are in high need of individuals who are skilled at managing, analysing, and interpreting data. Data literacy is deemed as a crucial…

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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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