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Risk Management - Volume 24, Issue

The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Origin and development of English for Medical Purposes. Part II: Research on spoken medical English - Volume 23, Issue

In the second part of the review on ‘English for Medical Purposes’, I present the main results of the research conducted on spoken interaction in medical settings. I start with those EMP studies that have a clear pedagogical goal, followed by EMP…

The request for proposal process: A brief overview for trainee medical writers - Volume 25, Issue

This article gives an overview of the request for proposal (RFP) process, which can often be challenging for those new to medical communications. Four key areas are outlined: understanding the RFP process, teamwork, the pitch process, and seeking…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

English Grammar and Style - Volume 22, Issue

Good writing practice is not a formal set of rules about how to write, like the requirements of GCP or GMP. Our aim is to highlight that the focus of all writers should always be on their readers, and that writers should make their texts as easy as…

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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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