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Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…
In this first issue of 2018, I’m delighted to introduce an excellent article from one of EMWA’s newest Workshop Leaders, John Dixon. Although John is new to teaching at EMWA, he’s extremely experienced in his field – or, more correctly, fields! John…
The characteristics of the clinical study protocol (CSP) are discussed with regard to (i) its structure and (ii) its development process. The benefits of medical-writing involvement into both aspects are highlighted. In particular, medical writers…
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…
Meeting reports are an aspect of ‘medical’ and other technical writing that has had little discussion. The following might be of interest to medical writers asked to provide rapid, reliable, objective reports of various types of meeting. The United…
The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…
Development of a patient publication steering committee (PPSC) is an innovation in industry publication practices. In this brief article, we summarise how UCB Pharma, a global biopharmaceutical company, plans to partner with patients to establish a…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
Artificial Intelligence (AI) and machine learning-driven software are evolving toward a technological advancement revolutionising the current global, social, and economic landscape. A major breakthrough in AI is the fast-growing natural language…
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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Alicia Brooks Waltman
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