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Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately…
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 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…
Welcome to Medical Writing’s first regular section on regulatory public disclosure (RPD). In this fast-evolving area, individuals can feel it’s almost impossible to keep up with developments.
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…
Keeping up with regulatory public disclosure (RPD) globally is a challenge for us all. This regular RPD section of Medical Writing and EMWA’s RPD Special Interest Group (SIG) help you stay ahead of the game through information sharing.
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…
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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