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Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…
Abstract Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data…
Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…
In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
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.…
Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…
Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…
The global population is ageing, but inequalities remain in older people's access to treatment, especially people 75 years of age and older. These people receive less frequent interventions and lower quality medical treatment than their younger…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
Medical translation training around Europe It’s been said a thousand times, yet, many are still not fully aware of the importance that translation has in our daily lives. Rather than merely supplanting one form of words with another, the translator…
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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