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Regulatory Writing - Volume 21, Issue

The Physicians Payment Sunshine Act – casting a shadow over clinical research? In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their…

The sun never sets on transparency - Volume 25, Issue

The financial relationships between the pharmaceutical and device industries and healthcare practitioners appear frequently in the spotlight because of their potential to create bias and influence prescribing choices. Public disclosure of these…

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers - Volume 29, Issue

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…

Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results - Volume 24, Issue

The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…

An interview with Cathal Gallagher of EMA’s Technical Anonymisation Group - Volume 29, Issue

In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…

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…

Regulatory Matters - Volume 32, Issue

Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…

Leveraging infographics in study schemas - Volume 29, Issue

Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Journal Watch - Volume 21, Issue

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…

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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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