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REACH chemical dossiers? Yes, please! - Volume 23, Issue

Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…

Pesticide dossiers, an opportunity for medical writers - Volume 23, Issue

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…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

Same but different: Basic tools for biosimilar and generic pharmacovigilance writing - Volume 28, Issue

Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,biosimilars and generics require the…

Planting a “non-biological” seed – will this meme persist? - Volume 29, Issue

Some word uses persist and some do not. Part of what makes use of a word stick is how catchy it is. This word is already used on our supermarket shelves. This proposed new use illuminates a small way in which language evolves. And it helps to…

Non-clinical health writing - Volume 23, Issue

We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…

Are stem cells the future of healthcare? - Volume 21, Issue

Stem cell technology holds a key, although arguably not an exclusive position, in the future of healthcare. Alongside two other candidates worthy of this mantle – personalized cancer medicine and vaccine development – all three healthcare…

My First Medical Writing - Volume 27, Issue

After the debut of the first edition of this section, I was honoured to be contacted by many aspiring medical writers eager to contribute and to showcase their writing skills. Among them, Matías Rey-Carrizo did anamazing job in translating a complex…

In vitro plants: How to open a jar containing bioactive phytochemicals - Volume 32, Issue

Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…

Regulatory pathways for development and submission activities - Volume 28, Issue

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…

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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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