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Considerations for the use of artificial intelligence in the creation of lay summaries of clinical trial results - Volume 34, Issue

The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…

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…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

News and Notes from the World of Medical Writing - Volume 30, Issue

The Philippine Association of Medical Journal Editors, Inc. (PAMJE) held its 3rd Annual Convention on September 20-23, 2021, with the theme, “Upholding Research Integrity in the Time of Pandemic.” The virtual event was attended by 392 participants…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

President’s Message - Volume 33, Issue

Welcome to the latest issue of Medical Writing. Following our record-breaking Spring conference in Valencia, Spain, which saw an unprecedented number of attendees, I am both humbled and excited to address you as the new President of EMWA. 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…

Journal Watch - Volume 21, Issue

Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…

Lingua Franca and Beyond - Volume 31, Issue

How to make our life easier? It was my pleasure to invite my colleagues from the European Association of Science Editors (EASE) to share their editorial experience with us medical writers. By doing this, we can improve our writing, which will…

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…

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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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