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This interview provides solutions to some of the common pitfalls that face medical writers when working with large teams. Practical tips are provided on key topics including manuscript planning, agreeing on key messages and the use of figures,…
Professional medical writers have an important role in facilitating the accurate and timely dissemination of medical and scientific data. This support should be appropriately acknowledged in peer-reviewed publications, but guidance on how to…
Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…
The EMWA autumn conference is always so well placed in November, giving us the chance to meet friends and colleagues before the onslaught of traditional end of year festivities. Barcelona's conference was no exception. We were pleased to welcome new …
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…
In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…
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…
Despite significant progress in tumour diagnosis and treatment over the last few years, cancer remains a major cause of death worldwide. Cancer prevention through diet and lifestyle changes is gaining importance, as our understanding of the…
Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…
Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…
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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