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December is traditionally a time of reflection, with an old calendar year drawing to a close, a new one just around the corner, and many of us planning to spend the festive period with friends and loved ones. On top of that, 2021 brings to a close…
Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…
The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…
Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…
During a visit to Greece more than 15 years ago when I was involved in an animal protection campaign, I met a journalist who was investi gating prohibited fishing methods that local fishermen were using. When he was asked by the animal protection…
The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
Time to say goodbye.As I will step down from my role as EMWA’s Public Relations Officer in May 2017, I will no longer be on top of the EMWA news and will, therefore, step down from my role as section editor. It is with great pleasure though that I…
The EMWA autumn conference is always so well placed in November, giving us the chance to meet friends and colleagues before the onslaught of traditional end of year festivities. Barcelona's conference was no exception. We were pleased to welcome new …
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
It is widely acknowledged that resolutions of difficulties tend to engender new problems. Increasingly, complex systems perpetuate increasing complexity. This discursive essay suggests that the most promising of discoveries, innovations, and…
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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