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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…

An interview with Research Policy and Initiatives Director Roseline Favresse at the European Organisation for Rare Diseases - Volume 34, Issue

Roseline Favresse is the Research Policy and Initiatives Director at the European Organisation for Rare Diseases (EURORDIS). We interviewed Roseline to learn more about the rare disease landscape within Europe and the exciting recent collaborations…

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

Foreword from the European Commission - Volume 31, Issue

Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…

From the Editor - Volume 33, Issue

On multilingualism and medical writing I arrived in Europe in September 1991 and was completely unprepared for the multilingualism of this continent. My first European home was the bilingual city of Brussels in the trilingual country of Belgium.…

Regulatory Writing - Volume 24, Issue

The Transatlantic Trade and Investment Partnership (TTIP) has attracted increasing controversy, particularly in Europe. The TTIP is a trade agreement under negotiation between the United States and the European Union, and affects three main areas:…

Clinical Investigations for Medical Devices - Volume 32, Issue

This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…

Snapshots from EMWA's 57th Conference - Valencia - Volume 33, Issue

The European Medical Writers Association (EMWA) 57th Conference May 7 –11, in Valencia, Spain, was an illustrious gathering that brought together medical writers, editors, researchers, and professionals from across Europe and beyond. The conference…

55th EMWA Conference - Volume 32, Issue

The 55th EMWA Conference took place on May 9–13, 2023, in Prague. With more than 400 participants from across Europe and the world, it was a rousing success. Topics of workshops and presentations ranged from the latest in regulatory writing and…

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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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