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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…

Clinical Evaluation Reports from the medical writer’s perspective! - Volume 26, Issue

Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

Collecting metrics in medical writing – the benefits to you and your business - Volume 28, Issue

Collecting and using metrics may not be at the forefront of all medical writers’ minds, but they can be an important asset to writers and managers, from freelancers to those working within companies, large or small. Keeping a record of pertinent…

In this issue… The Medical Writing Business - Volume 24, Issue

As medical writers, we strive not just to survive but to thrive. Threats, opportunities, and complications come from many directions, and how to best position ourselves, our departments, and our companies requires much thought. Money is important…

Oncology and medical writers - Volume 21, Issue

Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that is…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Position Statement - AMWA-EMWA-ISMP Joint Position Statement on Medical Publications, Preprints, and Peer Review - Volume 30, Issue

In medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and time-consuming process of the…

Medical writing in paediatrics: Children and the future - Volume 21, Issue

‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…

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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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