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Ingrid Edsman, with 17 years of increasingly senior clinical research positions in the Pharmaceutical Industry, is an expert in the preparation of regulatory and clinical documents. She obtained a Medical Degree at the Karolinska Institute in…
The right software can save you a lot of time and make your life much easier. You can choose from a huge range of packages for different medical writing or related activities. It is worth taking a look at what other medical writers recommend to use.…
See you in Valencia… Time is flying. We just left the autumn conference and now are approaching our main EMWA event – the spring conference, to take place May 7– 11, 2024. This time we go to Valencia, and I am sure that no one needs to be…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…
This article explores the role of translation and translators within the process of test adaptation. With similarities to the linguistic validation process in clinical research, test adaptation is a complex multistep and iterative process in which…
At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy,…
In the December 2014 issue of Medical Writing, I reported that disgraced Iowa State University researcher Dong-Pyou Han was facing fraud charges for faking experiments on a new HIV vaccine.1 In spite of a guilty plea, on 1 July 2015 Dr Han was…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…
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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