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Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
Abstract Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data…
The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…
Dear medical writers, Having embarked upon my year-long journey as president of EMWA, this is my first opportunity to update the members about the achievements, plans, and aspirations of the outgoing and new Executive Committee (EC). The…
Authors and co-authors This issue of Medical Writing is about Authors and Authorship, a topic, which despite stringent rules and regulations is sensitive, culturally-dependent and often full of emotion. I guess that we could have endless…
In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…
The Spanish Association of Medical Writers – in Spanish, the Asociación Española de Redactores de Textos Médicos (AERTeM) – is a young association focused on the specific needs of Spanish writers. Local organisations such as AERTeM can augment the…
In this issue • We continue Michael Schneir's fascinating series on distractions in medical and scientific writing, this time concentrating on non-pronoun-induced backtracking with adverbs, verbs, and nouns. This sounds a little…
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…
The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the…
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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