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Regulatory Writing - Volume 22, Issue

This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…

The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Strategic medical writing in the post-authorisation phase - Volume 23, Issue

This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…

How CDC is promoting a clear communication culture - Volume 24, Issue

Both the federal Plain Writing Act and the mission of the US Centers for Disease Control and Prevention (CDC) to protect and promote people's health require CDC to communicate clearly so that people can understand and act on the important health…

Announcing AERTeM, the Spanish Association of Medical Writers - Volume 22, Issue

The Spanish Association of Medical Writers – in Spanish, the Asociación Española de Redactores de Textos Médicos (AERTeM) – is a young association focused on the specific needs of Spanish writers. Local organisations such as AERTeM can augment the…

A primer on anonymisation - Volume 28, Issue

Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…

Improving patient communication by writing with empathy - Volume 21, Issue

Medical writers’ texts are either written for specialists or for non-professionals such as patients and their relatives. Medical writers whose work is intended for patients cannot merely impart facts. They also need to demonstrate that they…

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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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