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Medical researchers in Middle Eastern countries have been forced to confront the fact that scientific publication has become the cornerstone of knowledge dissemination and academic promotion. Regional initiatives, such as the foundation of the…
The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…
If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…
EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to…
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…
November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
The rise of ”predatory journals”, also known as pseudo-scientific journals, poses a risk to the integrity of science and therefore medical communicators need to know about their practices. Upon receipt of a publication fee, predatory journals…
Professional medical writers have an important role in facilitating the accurate and timely dissemination of medical and scientific data. This support should be appropriately acknowledged in peer-reviewed publications, but guidance on how to…
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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