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Challenges of paediatric drug development and impact of paediatric legislation - Volume 21, Issue

Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…

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…

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

Strategic medical writing in the post-authorisation phase - Volume 23, Issue

This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…

Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre? - Volume 24, Issue

Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…

Medical Devices - Volume 27, Issue

The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…

REACH chemical dossiers? Yes, please! - Volume 23, Issue

Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…

Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

Medical Devices: An exciting industry at a crossroads - Volume 26, Issue

Welcome to this special edition of Medical Writing focusing on medical devices. When I volunteered to act as the guest editor for this issue, I did so knowing that we are at a crossroads in Europe. The Medical Device Directive is about to be…

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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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