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Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

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…

Good clinical practice (GCP): A universal call for ethics in biomedical research - Volume 23, Issue

Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…

Oncology and medical writers - Volume 21, Issue

Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that is…

Medical Communications - Volume 26, Issue

Dear all,The legal side of our job is something that most of us usually give little thought to. We assume that as scientists, we are automatically on the “right side” and therefore pretty bulletproof. Why should the law affect us, as longas we have…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

The new PubMed – underestimated regulatory obstacles - Volume 29, Issue

NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…

Global perspectives on EDIB: Advancing equity, diversity, inclusion, and Belonging in medical communications - Volume 33, Issue

The integration of Equity, Diversity, Inclusion, and Belonging (EDIB) principles within the field of medical communications is of paramount importance. EDIB principles, aligned with global guidelines on sustainability – encompassing labour…

Medical writing around the world - Volume 22, Issue

As many of you are already familiar, Medical Writing began as The Write Stuff, a publication written by and for EMWA members. One of the goals in making the transition to Medical Writing was that it would become an international journal with readers…

Plain language and readability - Volume 24, Issue

Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…

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Scope

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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