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International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
After several lockdowns, “everyday” life is beginning to return, although COVID-19 continues to be a destructive force in many parts of the world. In Germany, where I am currently located, COVID-19 cases have been rather low (with occasional…
Having left the office for 5 days to go to the EMWA Spring Conference, I returned to the obligatory email avalanche. While it was mostly junk (and unfortunately still no ‘congratulations on winning the lottery’ message…), there were some messages…
The reach and impact of social media have made this communication channel the latest in a number of multidimensional communi - cation tools to be employed in health research. Social media has become a com - muni cation tool to reach various…
Below, two young colleagues share their experiences as mentees and the benefits they gained from such programmes. First, Geneviève Laumen tells it from the perspective of being part of an organised, structured mentorship. Next, Ivana Turek shares…
Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…
Dear all, When I wrote the editorial for this issue last year, I never dreamed that a year later we would still be dealing with global lockdowns and quarantines. I hope and pray that you and your loved ones are staying safe (and sane!). The Geoff…
The purpose of page layout is to consciously arrange text and graphics on a page in a way that supports the reading process and allows the reader to effortlessly follow the flow of information. It should blend words and images into an effective…
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.…
Almost everyone uses Microsoft Word® – but do you use its standard functions to the full to make your job easier? It is worth spending a little time getting to know how you can exploit functions like ‘Find and Replace’ or change or understand some…
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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