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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…

Lingua Franca and Beyond - Volume 24, Issue

Business models in the field of medical and regulatory writing – can you think of a more suitable topic for discussing: collaboration, team working, and sharing complementary skills across different native languages? In this issue of Medical…

Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry - Volume 32, Issue

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…

English Grammar and Style - Volume 22, Issue

We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…

Biosimilar development – an overview - Volume 28, Issue

Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

Lingua Franca and Beyond - Volume 24, Issue

Knowing that the main theme of this issue of Medical Writing is writing for the lay audience, I was thinking hard about what would be the most relevant topic to discuss in the Lingua Franca and Beyond section. My thoughts went to a topic that…

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

President’s Message - Volume 33, Issue

Navigating the new era of clinical trial transparency This issue of Medical Writing comes at a time when the summer holidays are behind us. Here’s hoping it has been a relaxing and rejuvenating time for all. As we get back to our day-to-day work,…

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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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