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Translating medical devices: A rule-driven game - Volume 33, Issue

Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

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…

Soft skills needed for freelance medical writers - Volume 32, Issue

Every professional needs to develop a set of hard skills and soft skills to grow and prosper in a designated field, and freelance medical writers are no exception. However, freelancing requires a unique combination of skills, given the independence…

Outgoing President’s Message - Volume 32, Issue

Over the finish line The remarkable success of EMWA’s 55th conference, held in Prague, seems as the perfect culmination of my one-year service as the EMWA president. Medical Writing. 2023;32(2)5. https://doi.org/10.56012/mnre9850

If a misinformed voice speaks out in the wilderness and no one refutes it, does it make a sound? A call to advocacy - Volume 22, Issue

The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the…

Digital Communication - Volume 32, Issue

Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…

English Grammar and Style - Volume 23, Issue

The purpose of the articles in the Good Writing Practice section is to focus on style, not on punctuation or grammar. However, apostrophes are a stumbling block for many writers and so require some discussion. Some people have simply not learned how…

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

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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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