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Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards - Volume 26, Issue

Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

Adverse event reporting: A brief overview of MedDRA - Volume 23, Issue

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…

Modern mentorship: Developing medical writing mentor-mentee relationships in the virtual world - Volume 30, Issue

Mentorship is often viewed as a traditional personal relationship model, where the mentor meets face-to-face with a mentee within the same organisation or group. However, I have been mentoring medical writers success fully for many years using…

Never say never! Returning to full-time employment after freelancing - Volume 25, Issue

Alison McIntosh successfully operated as a freelance medical writer for 14 years and gave up the ‘flexible lifestyle’ of a selfemployed freelance medical writer to become a full time employee. She has joined a growing band of ‘decentralised’ office…

Lingua Franca and Beyond - Volume 25, Issue

In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…

Is exercise physiology a real science? - Volume 21, Issue

Exercise physiology has not always been held with the same regard as other scientific disciplines. Despite the often held view that it is confined to the study of sport, exercise physiology has contributed to some of the most important scientific…

President's Column - Volume 27, Issue

Dear EMWA Members, As you are well aware, we have been celebrating our 25th anniversary as an organisation and have sent out specially designed buttons with the December issue of Medical Writing to commem - orate the occasion. To continue the…

NICE guidance on health technologies and the role of editors - Volume 22, Issue

The National Institute for Health and Care Excellence (NICE) is the independent organisation in England responsible for developing national guidance, standards, and information on providing high-quality health and social care, and preventing and…

Cost comparison of salaried and freelance medical writers working in Europe - Volume 23, Issue

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…

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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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