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The needs assessment in continuing medical education - Volume 23, Issue

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…

Statistical analyses and methods in the published literature: The SAMPL guidelines - Volume 25, Issue

Despite calls for guidelines on reporting statistical aspects of studies, most journals have still not included in their instructions for authors more than a paragraph or two about reporting statistical methods and results. However, given that many…

A shot at demystifying the risk management plan for medical writers - Volume 24, Issue

A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…

Medical Communication - Volume 27, Issue

At the start of a medical writing career, the quality control (QC) step can fill writers with a sense of dread. Someone is holding a magnifying glass to your carefully crafted (and at this point deeply loved) document and is trying to pick holes in…

From the Editor - Making responsible decisions – every day - Volume 30, Issue

For me, the most difficult task of medical writing is clicking that “SEND” button. After more than15 years in this field, the decision to send out and share a document with colleagues, regulatory authorities, even the public, is always accompanied…

Medical writing in India at a crossroads - Volume 22, Issue

Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…

The ABCs of paediatric plain language summaries - Volume 30, Issue

Plain language summaries need to be written at a proficiency level of 2 to 3, which roughly corresponds to a 6th grade to 8th grade reading level. Writing these for paediatric audiences brings even greater challenges. For communication to be…

English Grammar and Style - Volume 21, Issue

Pleasing the reader The fundamental principle in the practice of medicine, ‘first, do no harm’, could be transposed to the world of medical writing to ‘first, do not annoy’. The Good Writing Practice (GWP) group at EMWA has been focussing on…

Modern mentorship: Developing medical writing mentor-mentee relationships in the virtual world - Volume 30, Issue

Mentorship is often viewed as a traditional personal relationship model, where the mentor meets face-to-face with a mentee within the same organisation or group. However, I have been mentoring medical writers success fully for many years using…

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

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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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