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Out on Our Own - Volume 28, Issue

Back in 2016, the Out on Our Own editors reached out to groups in European countries who had established informal medical writers’ gatherings. It was great to see that groups had appeared in Germany, France, the UK, and the Netherlands. Here, I…

News from the EMA - Volume 33, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Section Editor: Anuradha Alahari Medical…

News from the EMA - Volume 33, Issue

Section Editor: Anuradha Alahari The articles included in this section are a selection from the European Medicines Agency’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Medical…

Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Medical writing in Italy in 2024: Results of the first Italian business and compensation survey - Volume 33, Issue

In Italy, little is known about the roles, activities, and compensation of medical writers and scientific communicators. A survey, tailored to local aspects and regulations, was conducted to capture a contemporary snapshot of the medical writing…

Writing for medical devices compared to pharmaceuticals: An introduction - Volume 26, Issue

Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR - Volume 29, Issue

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…

AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers - Volume 26, Issue

This joint position statement of the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) describes the appropriate role of…

Navigating the EMA clinical data website - Volume 27, Issue

This paper describes how to register, access, and navigate the EMA clinical data website. One of the authors (RB) is a medical writer and accessed the site from the perspective of a pharmaceutical industry professional. The other author (AS) is not…

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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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