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Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Your professional association: A great way to expand your skills and advance your career - Volume 22, Issue

Many medical writers and translators are not members of professional associations. While online networking is clearly accepted as a key element for success in business, the benefits of joining associations are still not obvious to all, even though…

Medical devices in the disclosure era and the role of medical writers - Volume 26, Issue

AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…

The war on cancer – What is the enemy, and are we winning? - Volume 21, Issue

The so-called ‘war on cancer’ is now in its fifth decade. This article presents some facts and figures about cancer and the effort to treat it. It outlines updated thinking on the hallmarks and classification of cancer, and draws together published…

An introduction to medical affairs for medical writers - Volume 28, Issue

The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

EMWA News - Volume 26, Issue

The 45th EMWA Conference in Cascais, Portugal, has recently finished and we are all waiting for the upcoming annual event in Barcelona, Spain, next Spring. In the meantime, the Executive Committee is working hard on improving what EMWA has to offer…

The Light Stuff - Volume 22, Issue

Decoding the Japanese Code 1: Yes means yes, and no does not exist At a recent dinner, my husband and I were chatting with a university professor, a Japanese fellow who has lived and worked in Europe and the US. We talked about cross-cultural…

Implications of clinical trial data sharing for medical writers - Volume 22, Issue

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…

In the Bookstores - Volume 23, Issue

To satisfy the inquisitive mind, Oxford University Press has since the year 2000 published books offering ‘A Very Short Introduction’ to a whole range of subjects. For example, 2013 saw the publication of introductory guides to, among other topics,…

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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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