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True journalism differs from public relations and uncritically reproducing press releases. It involves doing background research into the context surrounding the finding being reported, seeking comments from independent experts, and highlighting the…
The Chinese pharmaceutical regulatory landscape and medical publication policies have gone through drastic changes in recent years, and they continue to evolve. These changes provide great opportunities and many challenges to medical writers in…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
The needs assessment component of a continuing medical education grant proposal document describes why a specific programme should be developed. Medical writers frequently play a central role in producing the needs assessment as an important first…
Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…
Ellipsis is the absence of a portion of a syntactic unit in a stylistic effort to be succinct. For example, the ellipsis of that, in a noun clause occurring frequently in research writing, often is only a minor distraction (e.g., Smith hypothesised…
Section Editor: Lisa Chamberlain James Meet and Share session on protecting the public from undue harm during research studies (part 2): A report Author: Sampoorna Rappaz The Communicating with the Public Special Interest Group (CwP SIG) held in…
For this special Sustainability issue of Medical Writing, the editorial team at Veterinary Medical Writing has decided to focus on One Health. As the global society adjusts to adopting a sustainable lifestyle, whether voluntarily or kicking and…
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…
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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