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The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…
The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of…
Every discipline employs its own secretive words – jargon that allows initiates to communicate with one another in a way that excludes others. The world of medicine is no exception. The idioms used by doctors and surgeons range from the humorous to…
Having left the office for 5 days to go to the EMWA Spring Conference, I returned to the obligatory email avalanche. While it was mostly junk (and unfortunately still no ‘congratulations on winning the lottery’ message…), there were some messages…
The EMWA SIGs allow EMWA and its members to contribute to important conversations around topics that we know will impact on our industry in the coming years. You may have colleagues interested in joining the EMWA SIGs to debate, and share best…
The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…
What a busy time! The EMWA Professional Development Committee, the Conference Team, and the Executive committee are working very hard on organising the virtual conference in November, which we hope will be a unique experience for you. The…
In a post-pandemic world, master protocol studies will be an integral part of the “new normal” for clinical research and play an important role in providing actionable data to support health policy and resource allocation. Medical writers and study…
May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…
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…
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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