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Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

Teaching Medical Writing - Volume 26, Issue

Do you teach written English to non-native academics? Or are you a language editor or translator who would like to get involved in this sort of teaching? If so, we would very much like to hear from you. There are not many of us teaching in this…

My First Medical Writing - Volume 27, Issue

We all have been at the first stages of our careers, knowing what we want to do but without much experience. This is the case of many aspiring medical writers who come out of academia with a burning desire to becomemedical writers but without much…

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…

Value of medical writing: The regulator's perspective - Volume 31, Issue

In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s…

Writing applications for Paediatric Investigation Plans and waivers - Volume 21, Issue

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…

Ethical challenges in acknowledging professional writing support - Volume 29, Issue

Professional medical writers have an important role in facilitating the accurate and timely dissemination of medical and scientific data. This support should be appropriately acknowledged in peer-reviewed publications, but guidance on how to…

Medical writing in the era of artificial intelligence - Volume 28, Issue

The increasing amount of data available together with advances in computer science are converting computers from simple tools that execute commands into self-taught, self correcting machines that make decisions. This is the beginning of the era of…

A medical writing primer for oncology dossiers - Volume 31, Issue

Oncology is one of the most common areas of drug development in the pharmaceutical industry. As a medical writer, it is important to be aware of the unique aspects of oncology studies and have some understanding of the principles underlying cancer…

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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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