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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…

The changing face of medical writing in India - Volume 22, Issue

Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…

Medical writing in the era of artificial intelligence - Volume 28, Issue

The increasing amount of data available together with advances in computer science are converting computers from simple tools that execute commands into self-taught, self correcting machines that make decisions. This is the beginning of the era of…

A PhD and medical writing: A good match - Volume 25, Issue

The transition out of academia can involve a good deal of change. For PhDs who enjoy writing, a career in medical communications is a viable option. The field of medical writing is broad, encompassing everything from regulatory affairs, to writing…

HIV vaccine clinical trials: An overview - Volume 27, Issue

More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…

Big data in clinical research: Present and future - Volume 29, Issue

The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

Creation of a patient-centric patient lay summary in the local language - Volume 26, Issue

Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the…

An interview with Cathal Gallagher of EMA’s Technical Anonymisation Group - Volume 29, Issue

In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…

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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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