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In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…
The Sustainable Development Goals, set up by the UN in 2015, provide a framework for the policy makers in government and other advocates to work towards planetary health in a more holistic way. For the general public, these goals might not always be…
A podcast is a digital audio file that can be downloaded into your computer or mobile device. It is typically available as a series, and new episodes can be received automatically by subscribers. Podcasts are a source ofeducation, inspiration, and…
More and more, computers must participate with physicians and patients as trusted partners in assessing medical options and tracking outcomes. But before the computer can become a routine medical assistant, data and computational services must…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…
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…
The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
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…
The needs assessment component of a continuing medical education grant proposal document describes why a specific programme should be developed. Medical writers frequently play a central role in producing the needs assessment as an important first…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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My First Medical Writing
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
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Chris Monk