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International teams: How to survive a long-distance work relationship among medical writers - Volume 31, Issue

How does a team of medical writers working in different countries navigate different time zones and cultures to get their work done remotely? In this interview, a team of six medical writers and one editor working at P95, a private research…

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…

Medical Communication - Volume 22, Issue

Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…

Regulatory writing basics - Volume 23, Issue

The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

The medical writers role in health technology assessment submissions - Volume 30, Issue

Writing health technology assessment (HTA) submissions is a challenging and rewarding area of medical writing, being part of the process of giving patients access to new medicines. Submission requirements differ between countries but all require…

Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Lay writing: Strategies for improving assent forms - Volume 27, Issue

Writing for lay audiences is recognised as a difficult task for medical writers, whose specialised knowledge can often hinder effective lay communication. This task is even more challenging when preparing clinical trial information for a…

Inclusive language in medical texts and medical translation in French - Volume 33, Issue

In French, the grammatical rule of the generic masculine, known as neutral, reveals a patriarchal worldview. This article looks at the consequences of this way of writing in medical texts and in medical translation. It also gives suggestions on how…

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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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