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Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…
The first thing we must say is a huge “thank you” to Dr Juan Garcia Burgos and Mr Paul Blake for taking the time in an unprecedentedly manic year for the EMA to write a foreword for this issue of Medical Writing. The fact that they have prioritised…
At the outset of the pandemic, it became clear that misinformation (“fake news”) on COVID-19 was spreading rapidly. In this article, we discuss our efforts to combat misinformation by joining with researchers from various disciplines in Argentina to…
My first 39 myths about English were published in The Write Stuff in a series of articles between January 2006 and January 2008. The myths are mainly drawn from claims about English made by participants at my training events on the use of English…
Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…
Concise medical and scientific writing is clearer, more direct, and more pleasurable to read than wordy text. It is also more accessible to readers, including those outside the discipline and non-native speakers of English. An added benefit of…
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…
Mentorship is a topic very close to my heart. If it were not for the numerous mentors in both my academic and professional life, I would not be here today. The definition of mentorship is subjective and how a mentor operates is often up to those…
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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