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Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators…
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…
Pradaxa, a new drug for the treatment of blood clots, has been revealed to produce some negative side effects on a minor population of patients, according to a new study. However, the road leading to the publication of this study revealed that…
I'm sitting down to write this having just returned from the DIA Euro meeting in Amsterdam. As always, it was a busy and successful meeting, with many ‘themes’ of presentations being given at once. However, this year there were many presentations…
Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…
Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
The global population is ageing, but inequalities remain in older people's access to treatment, especially people 75 years of age and older. These people receive less frequent interventions and lower quality medical treatment than their younger…
This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…
Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…
The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
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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