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The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Among the highlights of the November 2015 issue of European Science Editing (ESE) is an essay on whether interpretation of research ethics is universal. Writing from an Iranian perspective, Behrooz Astaneh describes how cultural norms and inadequate…
Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in…
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,…
In 2004, health technology assessment (HTA) was recognised as a ‘political priority’ by the EC and Council of Ministers, which led to a call to establish an effective and sustainable European network for HTA (EUnetHTA). The result was the…
This is an article about my returning back to India from Europe and transition from research career to a profession of medical writing. I was introduced to medical writing through European Medical Writers Association (EMWA) while I was in Europe.…
This is the first systematic comparison of the costs of salaried and freelance medical writers working in Europe. In the absence of official figures for the total costs of employment, we make reasoned assumptions, using mean base figures for…
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…
A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…
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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