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A lot was going on from April to June this year. Certainly the main event was our spring conference in Munich. Aside the established workshops, Freelance Business Forum, Expert Seminar Series, and updates on Special Interest Groups – it included an…
This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…
Clear communication with the public and with potential clinical trial participants and their caregivers is foundational to the ethical tenets of respect, justice, and beneficence. However, health literacy, even of highly educated individuals, often…
The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…
Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…
Greetings, readers.In this issue of OOOO, we start off with an important question – how do I prevent the risk of working too much? An apt question as we approach the end of the year, finishing up our projects and settling in to enjoy the holiday…
Whoever writes wants to be read. Yet, even if we succeed in creating an informative, logically structured, and adequately worded text tailored to our target audience, i.e., text we consider to have an adequate level of readability, our documents may…
Have you been commissioned to write a review? Reviews are useful for drawing attention to issues and benefits related to a product. One thing they are not, however, is something to be feared, if you are organised and have a clear idea from the…
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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