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An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

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…

In the Bookstores - Volume 26, Issue

A research paper is often the culmination of years’ worth of data and experiments, successes and failures, doubts and triumphs, as well as a balancing act between many different opinions from different authors. Writing one can be a daunting task,…

Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare - Volume 23, Issue

Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…

Regulatory Matters - Volume 28, Issue

Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…

Teaching Medical Writing - Volume 28, Issue

The training of medical writers is not to be taken lightly and requires serious input from industry, established medical writers, and the academics making the transition. Following on from previous articles in Medical Writing, Sarah and Adrian Tilly…

Mentorship from the inside - Volume 30, Issue

In this article we interview Jose Francisco Sanchez Herrero from the Germán Trias i Pujol Institute in Badalona. He is Selma’s tutor and gives us a glimpse of what it is like to be a mentor in an academic setting. If there is one thing we learned…

The Investigator's Brochure: A multidisciplinary document - Volume 23, Issue

The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…

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…

Post-approval regulatory writing – How different is it from writing pre-approval documents? - Volume 23, Issue

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…

In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

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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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