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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…

Cosmetic regulatory writing - Volume 23, Issue

On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…

Leveraging standardised data in response to the novel coronavirus outbreak - Volume 29, Issue

As we are confronted by a new global health epidemic in the form of COVID-19, the challenges and opportunities of global data sharing come into sharp focus. Due to significant data collection and sharing issues during the 2013–2016 Ebola outbreak,…

From the Editor - On journalism, the Nobel Peace Prize, and the paths we travel by - Volume 30, Issue

The road to a Nobel Prize is not easy and journalist Maria Ressa can attest to that. I am both awed and inspired by her journey and find it fitting to pay tribute to her achievement in this issue on medical journalism. I must admit I am biased due…

Update of the Consolidated Health Economic Evaluation Reporting Standards: CHEERS 2022 - Volume 31, Issue

If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…

Getting Your Foot in the Door - Volume 31, Issue

“Do your homework, knowledge is power!” my teachers used to say. Yes, we learn a lot during our education, respect the rules of the system, and we rely on that knowledge. However, once that stage is over, we are overwhelmed with possibilities and sta…

The Crofter: Sustainable Communications - Volume 31, Issue

Greetings from the croft! As a member of the EMWA’s Sustainability Special Interest Group (SUSSIG), I’m excited about this issue of Medical Writing focusing on sustainability. There are so many aspects of sustainability and recently, the link to the…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Winner of the Geoff Hall Scholarship Essay Competition - Volume 31, Issue

The Geoff Hall Scholarships are given in honour of the former President of EMWA. Geoff was a very special person, an extremely valued member of EMWA, and a very good friend to many EMWA members. He firmly believed that the future of EMWA lies in our…

Pharmacovigilance - Volume 31, Issue

The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…

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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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