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Regulatory Public Disclosure - Volume 31, Issue

A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…

The Lay Protocol Synopsis: Requirements and feasibility - Volume 32, Issue

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…

A history of EMWA - Volume 27, Issue

EMWA has now been in existence for 25 years! How is that possible? Time has flown by, and brought with it much change and growth of which we should be proud. This is an oppor tunity to reflect back on the organisation as it was at its genesis, is…

Carbon footprint of EMWA activities: A first estimate - Volume 32, Issue

The Sustainability Special Interest Group (SUS-SIG) of EMWA was established in 2020 to support the United Nations 2030 agenda for sustainable development from the perspective of a not-for-profit professional organisation for medical writers and…

Introducing EMWA’s new AI Working Group - Volume 32, Issue

Artificial Intelligence (AI) is a broad umbrella term that refers to the use of computer algorithms to perform tasks that typically require human-like intelligence, such as reasoning, learning, decision-making, and perception. The new EMWA AI…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

In the Bookstores - Volume 24, Issue

Statistical Thinking for Non-Statisticians in Drug Regulation (Second Edition) By John Wiley & Sons, 2014. ISBN: 978-1-118-47094-7 (hardcover).59.99 GBP. 368 pages. Writing for Science Journals: Tips, Tricks, and a Learning Plan By Geoff…

Vaccines and immunotherapies - Volume 27, Issue

The use of vaccines and immunotherapies in medicine dates back to the end of the 18th century and the work of Edward Jenner, the father of immunology. Jenner, building on the observations of John Fewster in 1768, showed that inoculation with the…

Medical Devices - Volume 27, Issue

The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…

Out on Our Own - Volume 28, Issue

It is a pleasure for me to share an article in this issue from our previous Out on Our Own (OOOO) section editor, Satyen Shenoy. For those that don’t know him, where have you been? Satyen, as he will describe, has been on the EMWA scene for many…

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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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