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Remote working is ideal for medical writers, but up until a few years ago, was not widely available to those looking for a remote position with a German employer. Even though Germany is a developed country, its digitalisation has long been lagging,…
Diabetes is one of the most common chronic diseases and is estimated to affect more than 32 million European Union (EU) citizens, which is nearly 10% of the total EU population. An additional 32 million EU citizens are not yet diagnosed or have…
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…
Poacher turned gamekeeper Medical writing is a collaborative process. Medical writers seldom write about their own research. Typically other people do the research, and the medical writer writes about it. Whether the writing is for a study report…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…
EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…
Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…
Medical writing demands a comprehensive set of technical skills, from mastering regulatory and ethical guidelines to honing exceptional writing abilities. The foundation of superior medical writing is built on the hard skills acquired through educati…
Professor Matthias Rose is Medical Director of the Psychosomatic Department at the Charité University Hospital in Berlin, Germany. In this interview, I discuss with him patient-reported outcomes and the Patient-Reported Outcomes Measurement…
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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