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HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…
Editorial Who is qualified to author a medical translation? This is one of those topics that we often read about on professional translation forums and discussion groups. It is, indeed, a never ending discussion.
Welcome to this special edition of Medical Writing focusing on medical devices. When I volunteered to act as the guest editor for this issue, I did so knowing that we are at a crossroads in Europe. The Medical Device Directive is about to be…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…
The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
When I attended my first conference as Public Relations Officer in Dublin, I was approached by “newbies” looking for a job. I was quite impressed that people invested such a considerable amount of money to attend the conference in the hope of…
Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines 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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