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Collecting and using metrics may not be at the forefront of all medical writers’ minds, but they can be an important asset to writers and managers, from freelancers to those working within companies, large or small. Keeping a record of pertinent…
This book is regarded by many as the holy grail of reference manuals. For those not familiar with the great tome it contains a massive amount of information regarding ‘publication style and format for scientific papers, journal articles, books, and…
A skilled mentor can positively impact a mentee’s personal and professional development. A successful mentor-mentee relationship is contingent on mentor and mentee attributes, trust, and respect, and fit based on shared values and working style. To…
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…
Doughnut economics provides a new framework for sustainable development, by balancing the ecological boundaries of the planet with the social boundaries of humanity. The framework provides a valuable opportunity for the healthcare industry to…
Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…
In this article, I explain my route into the world of rare conditions, my experience of working as a clinician, and my passion for raising awareness to all involved. I achieve this by providing education to healthcare professionals, patients, and…
Evidence derived from real-world data is invaluable for expanding knowledge about medicines. As medical writers, we need to understand how to think about, handle, and communicate these data to ensure that they are credible and have a meaningful…
Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…
The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…
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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