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Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

Medicinal products and medical devices in clinical trials conduct and disclosure - Volume 28, Issue

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No.…

Out On Our Own - Volume 22, Issue

The fourth EMWA freelance business survey Introduction This fourth survey follows those conducted in 2003, 2007, and 2010.1–3 The first survey was conducted with a paper questionnaire distributed to both freelancers and small businesses…

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR - Volume 29, Issue

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…

Authorship of clinical trial documents - Volume 25, Issue

Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…

Can a medical writer submit a manuscript on behalf of a corresponding author? - Volume 26, Issue

Abstract Medical writers are frequently asked to submit manuscripts to journals using the corresponding author’s login information. However, according to the Recommend a - tions of the International Committee for Medical Journal Editors, this is not…

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:…

AI-based plagiarism detectors: Plagiarism fighters or makers? - Volume 32, Issue

Plagiarism damages the biomedical academic publication domain. Artificial intelligence (AI) is a rising hope in academic plagiarism hunting. However, new AI-based tools are available online to assist with plagiarising! This article presents…

What is the best quality of diabetes care? The Global Diabetes Survey needs your participation - Volume 21, Issue

Adequate quality of diabetes care and the best concept for the implementation of national diabetes plans remains controversial. In September 2011, the United Nations Summit for Non-Communicable Diseases agreed that national plans for prevention and…

Challenges of working from home during the COVID-19 pandemic: A survey to inform working practices - Volume 30, Issue

In response to the COVID-19 pandemic working practices changed for members of the medical communication community. We devised a multifactorial online survey to better understand the impact of these changes. Of the 759 respondents, 85% had a positive…

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Scope

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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