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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…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
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…
Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…
Embracing artificial intelligence in medical writing: A new era of efficiency and collaboration Authors: Sofie Bergstrand, Catherine Heddle, Montse Sabaté, Marta Mas Section Editor: Nicole Bezuidenhout Artificial intelligence (AI) tools have…
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…
What Every Medical Writer Needs to Know: Questions and Answers for the Serious Medical Author They say “don’t judge a book by its cover”, but the title of this book lends itself to curiosity. In What Every Medical Writer Needs to Know, Dr Robert B.…
Introducing a new EMWA Special Interest Group: Communicating with the Public Contributors: Sampoorna Rappaz (author), Lisa Chamberlain James (section editor) The Communicating with the Public Special Interest Group (CwP SIG) held its first Meet…
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 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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