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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…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

Clinical trial results disclosure on ClinicalTrials.gov and EudraCT - Volume 27, Issue

The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available…

Lay titles for clinical trials: A balancing act - Volume 27, Issue

With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the…

Writing lay summaries: What medical writers need to know - Volume 27, Issue

Lay summaries are critical for building publictrust in clinical research and therefore forrecruiting patients. They are also an importantpart of efforts to improve data transparency.Due to new global regulations, lay summarieswill soon probably…

Clinical trial disclosure and transparency - Volume 27, Issue

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 Webscout - Volume 26, Issue

Preclinical studies –is animal testing necessary?The drug regulatory authorities require testing in animals, to be exact in at least two mammalian species, before the first-in-human trials can be approved. Common criticism is that the results from…

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…

Drug development and medical writing in the digital world - Volume 28, Issue

Artificial intelligence and digital health open a new chapter in the pharmaceutical industry. The digital technologies improve work efficiency, lower research and development costs, optimise medical research processes, and increase R&D outputs.…

Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin - Volume 32, Issue

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…

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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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