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News from the EMA - Volume 33, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Section Editor: Anuradha Alahari Medical…

News from the EMA - Volume 33, Issue

Section Editor: Anuradha Alahari The articles included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Medical…

News from the EMA - Volume 26, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from July 2017 to September 2017. More information can be found on the Agency’s website: www.ema.europa.eu

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout Purr-fecting translation: Unleashing the power of computer-assisted translation (CAT) tools Author: Natasha Grande de França Medical translations are fundamental, and precision is at the core of this work. Any…

“Follow the Sun” writing: A hybrid operating model to optimize collaboration and efficiency - Volume 33, Issue

Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…

Authorship of clinical trial documents - Volume 25, Issue

Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…

From researcher in Europe to medical writer in India - Volume 21, Issue

This is an article about my returning back to India from Europe and transition from research career to a profession of medical writing. I was introduced to medical writing through European Medical Writers Association (EMWA) while I was in Europe.…

Regulatory Writing - Volume 22, Issue

This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…

HTA decision-making: Do ethics matter? - Volume 30, Issue

Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…

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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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