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Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
Medical Devices Section Editor: Payal Bhatia Medical devices can be orphans, too Author: Raquel Billiones Medical Writing. 2025;34(1):66. https://doi.org/10.56012/beyk2425
The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…
Medical devices should certainly be included on any list of trends in medical writing. That impression was only reinforced by the strong interest in device writing evident at this year’s EMWA spring conference. The three medical device workshops on…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…
Co-development, co-delivery, and evaluation of a Medical Writing module at master’s level Few universities offer courses in medical writing, and students from the biomedical sciences who wish to become medical writers typically need to learn…
In French, the grammatical rule of the generic masculine, known as neutral, reveals a patriarchal worldview. This article looks at the consequences of this way of writing in medical texts and in medical translation. It also gives suggestions on how…
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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