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Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…
The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
In the world of regulatory public disclosure (RPD) things rarely stay the same for long. This regular RPD section in Medical Writing and EMWA’s RPD SIG help you keep up.
In this information-packed edition of Regulatory Public Discussion, Sam Hamilton provides detailed comparisons of regulatory templates and updates on processes for the Clinical Trials Information System. Contributor: Sam Hamilton (author and…
Ensuring population diversity in clinical trials is essential yet challenging and increasingly complex in the rare disease landscape. The unique challenges in clinical development for rare diseases include limited medical and scientific knowledge,…
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…
Calling all medical writers:
Focus your writing with lean authoring
In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…
Emotional intelligence (EI), the ability to recognise and understand emotions (one’s own and those of other people), is a valuable attribute for medical writers (MWs). MWs play a pivotal role in communicating medical and scientific information to…
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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