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Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…
Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…
The EMWA Executive Committee and Head Office closely monitored the rapidly evolving implications of the current COVID-19 situation and the recommendations from the World Health Organization as well as the advice from and restrictions implemented by…
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…
While disclosure of individual clinical study reports (CSRs) is becoming common globally, this is not yet the case in Japan, where the national health authority does not require CSRs to be made publicly available. As CSRs of Japanese studies might…
Dear friends, colleagues, and EMWA members, despite the global COVID-19 pandemic and the war in the Ukraine, EMWA’s financial situation and membership numbers remained stable over my term of presidency. In fact, membership numbers slightly…
The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…
Greeting from the croft! During my non-linear career path, there has been one recurring theme that always rang true: “Context matters”. As a physical therapist working in a rehabilitation centre, understanding my clients’ social roles, home…
What is a modern mentorship, how do you make it work, and what does gardening have to do with it? Let us take you on a tour of the growing garden of our own modern mentorship, showing how we as a medical writer (Lillian Sandø; mentor) and a clinical…
Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…
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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