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Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

Clinical Trials in the Eurasian Economic Union - Volume 32, Issue

In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory…

Teaching Medical Writing - Volume 26, Issue

Do you teach written English to non-native academics? Or are you a language editor or translator who would like to get involved in this sort of teaching? If so, we would very much like to hear from you. There are not many of us teaching in this…

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…

Key factors a pharmaceutical company should consider while outsourcing medical writing services - Volume 23, Issue

Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…

Cheeky medical writers: Transitioning from academia to medical writing - Volume 28, Issue

Many PhDs and postdocs in academia realise that they do not have such a strong passion for the bench, so some dream of becoming medical writers, but they often lack the information, training, connections, experience, and (most importantly)…

EU software regulations: The new normal or innovation stagnation? - Volume 29, Issue

Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…

Teaching Medical Writing - Volume 28, Issue

The training of medical writers is not to be taken lightly and requires serious input from industry, established medical writers, and the academics making the transition. Following on from previous articles in Medical Writing, Sarah and Adrian Tilly…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…

Good Writing Practice - Volume 27, Issue

Nominalisation is the transformation of a precise verb into another sentence constituent, usually a noun (nominalisation), sometimes an adjective (adjectivalisation). This syntactic transformation elicits the grammatical necessity to add…

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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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