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A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Bioanalytical reports are usually written by bioanalysts. Medical writers offer a valuable contribution to bioanalytical reporting, increasing the efficiency of document development and improving the quality of data presentation. This article…
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…
Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…
‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…
I can't believe that my two years on the Executive Committee are now complete – what a journey from Manchester and Barcelona in 2013, Budapest and Florence in 2014, and finally Dublin in 2015. Apart from travelling many miles, I have had a great…
The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
As medical writers, we fall within the field of professional writing. Writing well should be essential for us. Unfortunately, training on how to write well specific to our field is hard to come by. Most books focus on preparing scientific articles…
Dear EMWA MembersI was asked if the time between conferences is a quiet time. Having been in post just over 2 months at the time of preparing this report, I can most definitely state – NO! New initiatives are regularly proposed and I am often…
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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