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I am pleased to share an article by an aspiring medical writer from Poland. Hanna KurlandaWitek finished her PhD in geoscience at the University of Edinburgh, specialising in microbiology. After working in an environmental consultancy for a few…
As pharma companies strive for carbon neutrality, carbon accounting is now part of day-to-day business; the carbon footprint for each process, each step, and each stakeholder is closely scrutinised. Freelance medical writers and communicators as busi…
A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply of providers. The challenge that arises in such a…
On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…
A document template is defined as ‘a file that serves as a starting point for a new document’. This article looks at the specialised templates used by medical writers in their trade with a focus on the commercially available products. Templates…
Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a…
According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical…
While disclosure of individual clinical study reports (CSRs) is becoming common globally, this is not yet the case in Japan, where the national health authority does not require CSRs to be made publicly available. As CSRs of Japanese studies might…
Medical writers at EMA have published an “EMA medical terms simplifier” (https://www.ema.europa.eu/en/documents/ot her/ema-medical-terms-simplifier_ en.pdf) on the “Glossaries” page of EMA’s website (under “About us”) to provide public-friendly…
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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