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We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…
Health literacy is defined as “the knowledge, motivation, and competence to access, understand, appraise and apply information to make decisions in terms of healthcare, disease prevention, and health promotion” according to Quaglio et al.5 Poor…
Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important…
The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
This roundup of news from the EMA includes information on vaccines to protect against dengue, therapy to treat transplant patients with post-transplant lymphoproliferative disease, the withdrawal of marketing authorisations for amfepramone…
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…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
I must admit to feeling very strongly about information that is written for patients – both about the quality and the appropriateness of the information itself, and about how it is communicated. Thankfully, this topic is now enjoying some long…
As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…
Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…
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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