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The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…
In our daily work as coaches and writing trainers, we often work with young scientists who are at the beginning of their careers. When they want to publish their first scientific research paper or when they decide to give their first lecture at an…
In this article, the authors outline the universal right to health, healthcare, and language access in healthcare, with a focus on policies and practices in the European Union and the United States. The authors spotlight contrasting views on whether…
The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…
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…
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…
Patient-reported outcomes (PROs) are any report on the status of a patient’s health condition as told by the patient him or herself or through an interview, without any interpretation by a clinician or anyone else. They generate information on those…
This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…
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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