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Out On Our Own - Volume 21, Issue

Successful migration from the personal computing to Apple computing environment for regulatory medical writers When renewing computer hardware, migration from one system to another, arguably, should not be overlooked. Some of the challenges…

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…

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…

Predatory publishing – what medical communicators need to know - Volume 28, Issue

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…

Writing economically in medicine and science: Tips for tackling wordiness - Volume 26, Issue

Concise medical and scientific writing is clearer, more direct, and more pleasurable to read than wordy text. It is also more accessible to readers, including those outside the discipline and non-native speakers of English. An added benefit of…

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…

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,…

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…

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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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