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News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

Medical writing education - Volume 22, Issue

Although medical writing as a career has been around for a few decades, medical writing education is relatively new. Many medical writers end up teaching scientific or medical writing, and have built their courses and their teaching style without…

AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing - Volume 28, Issue

The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) recognise the challenges to scientific publishing being posed by predatory…

Thriving (and not just surviving) in a VUCA healthcare industry - Volume 28, Issue

VUCA stands for volatility, uncertainty, complexity, and ambiguity. The healthcare sector is considered a VUCA industry, constantly changing through rampant mergers and acquisitions, rapidly evolving regulations, and leading-edge innovations. So how…

News and Notes from the World of Medical Writing - Volume 30, Issue

EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

Writing publications for advisory boards - Volume 23, Issue

Medical communication publications are designed to raise awareness of medicines, cosmetics, and technology. These publications ensure that doctors are informed about the role of new and existing medicines and the literature concerning appropriate…

In this issue of Medical Writing - Volume 23, Issue

Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…

Medical Devices - Volume 29, Issue

May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

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…

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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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