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Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

Pleasing the reader by pleasing the eye—Part 2 Page layout and readability - Volume 22, Issue

The purpose of page layout is to consciously arrange text and graphics on a page in a way that supports the reading process and allows the reader to effortlessly follow the flow of information. It should blend words and images into an effective…

Profile: An interview with Art Gertel on the Budapest Working Group - Volume 24, Issue

Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…

EMWA’s newest special interest group: Sustainability SIG - Volume 29, Issue

In 2015, the United Nations set 17 Sustainable Developments Goals (SDGs, Figure 1) as a “universal call to action to end poverty, protect the planet, and ensure that all people enjoy peace and prosperity by 2030”.1 Central to these SDGs is planetary…

A wonderful "Medium" for medical writers - Volume 30, Issue

With the advent of social media platforms and the increasing availability and access of information on the internet, we are not limited by information sources on any subject. Medium.com, since its inception in 2012, has become a very good blogging…

Lay titles for clinical trials: A balancing act - Volume 27, Issue

With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the…

Good Writing Practice - Volume 25, Issue

Personalism results from a story-line narration rather than a thematic-focused description. This story-line narration is focused on agents as sentence (or clause) subjects and their actions as verbs, rather than themes represented by noun subjects…

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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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