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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.…
Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…
NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…
One spring morning, I was wandering ‘lonely as a cloud’ with a ‘host of golden daffodils’ before me. Then someone stopped me in my tracks: What do you think of the changes in Big Pharma? The illusion was shattered. There was an ominous…
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
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…
We are living in an era of data deluge. With the amount of data generated increasing rapidly, organisations are in high need of individuals who are skilled at managing, analysing, and interpreting data. Data literacy is deemed as a crucial…
There are different definitions of the adjective ‘good’, e.g. morally excellent; satisfactory in quality, quantity or degree; of high quality; excellent; well-behaved; etc. as the web dictionary tells us. In ‘good pharma’ the meaning of ‘good’ is…
Decoding the Japanese Code 1: Yes means yes, and no does not exist At a recent dinner, my husband and I were chatting with a university professor, a Japanese fellow who has lived and worked in Europe and the US. We talked about cross-cultural…
This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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Alicia Brooks Waltman
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My First Medical Writing
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