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Thousands of clinical trials are conducted globally each year. Yet, little is known about their environmental impact. This paper presents the results of a high-level literature review of the carbon footprint of clinical trials. Five papers were…
Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…
Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…
Concise medical and scientific writing is clearer, more direct, and more pleasurable to read than wordy text. It is also more accessible to readers, including those outside the discipline and non-native speakers of English. An added benefit of…
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…
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…
When I was asked to write about using social media for work and collaboration, one “professional” social media platform immediately sprang to mind – LinkedIn. This article discusses LinkedIn, one of many social media platforms in a prosperous…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
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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