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Type 2 diabetes (T2D) has become a burden for society, and the incidence of the disease continues to increase. A range of therapies is available to control glycaemia in T2D patients; however, these drugs have undesired side-effects and there is a…
Alison McIntosh successfully operated as a freelance medical writer for 14 years and gave up the ‘flexible lifestyle’ of a selfemployed freelance medical writer to become a full time employee. She has joined a growing band of ‘decentralised’ office…
Over the centuries people have become taller, heavier, and stronger. One of the major reasons for this is the increasing supply of calories in our diets. In earlier times, weight gain was extremely beneficial for health, well-being, and lifespan,…
Medical researchers in Middle Eastern countries have been forced to confront the fact that scientific publication has become the cornerstone of knowledge dissemination and academic promotion. Regional initiatives, such as the foundation of the…
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)…
Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…
Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…
Lay summaries are critical for building publictrust in clinical research and therefore forrecruiting patients. They are also an importantpart of efforts to improve data transparency.Due to new global regulations, lay summarieswill soon probably…
With spring comes a renewed sense of optimism. A good time, perhaps, to review where we are in our businesses and consider how we can improve. Michelle Storm Lane of the Association of Independent Professionals and the Self Employed (IPSE) provides…
Quality matters in medical translation In recent years, ‘translation quality’ has become a buzzword in the translation industry. Particularly since the introduction of European standard EN 150381 in 2006 and the certification process that has come…
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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