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Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

The hard truth about soft skills in medical writing - Volume 33, Issue

Historically, hard skills – such as technical, digital, or life sciences qualifications – have been seen as more valuable than soft skills in successful medical writing. However, hiring managers now recognise soft skills as one of the top…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

Manuscript Writing - Volume 21, Issue

Help, I can't shorten my abstract! Oh yes you can! (Part 1 of 2) Abstracts are perhaps the most important part of a manuscript because they are often the only part that is read and used as an information source. They are also used by readers…

Manuscript Writing - Volume 21, Issue

Help, I can't shorten my abstract! Oh, yes you can (Part 2 of 2) Abstracts may be the most important part of a manuscript because they are often the only part that is read and used as an information source, and because they are also used by readers…

Regulatory Writing: New developments in public disclosure of clinical trials - Volume 24, Issue

In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement…

A decade of change: A new ISMPP has arrived - Volume 22, Issue

Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over…

Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance - Volume 24, Issue

To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no…

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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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