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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…
For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…
There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…
Dear MEW reader Welcome to the first 2012 Medical Writing or MEW issue – another EMWA milestone to start off this stellar year. I hope you enjoy the new design and the thematic focus on oncology. The theme of EMWA's upcoming 34th Spring conference…
Science at the multilingual crossroads With Medical Writing's third issue, this seems to be a good time to recall why this journal features a section on multilingual aspects – and why this section is called what it's called. Medical writing,…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…
Modern data legislation increasingly empowers citizens, and therefore patients, with rights to access and control their health data. The mechanisms needed to exercise modern data rights are currently underdeveloped and underserving individuals and…
Dear EMWA Members,The time has been passing so quickly, with 2017 coming to an end and the holiday season now upon us.I am sure we all have enjoyable memories of our very successful conference in beautiful Cascais. Since my last message, the…
An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…
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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