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Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

The COVID-19 pandemic as a catalyst for digitalisation and remote working in Germany - Volume 31, Issue

Remote working is ideal for medical writers, but up until a few years ago, was not widely available to those looking for a remote position with a German employer. Even though Germany is a developed country, its digitalisation has long been lagging,…

AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers - Volume 26, Issue

This joint position statement of the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) describes the appropriate role 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…

Abstracts from 44th EMWA conference Poster session - Volume 26, Issue

At this year’s Spring Conference in Birmingham, UK, EMWA held its second annual poster session. Six poster presentations were selected from abstracts submitted to the Educational Committee. Abstracts could be on any subject related to medical…

Getting Your Foot in the Door - Volume 27, Issue

Landing the first medical writing job is not easy. Clare Chang’s contribution describes her journey, the challenges she faced, and the different measures she took to overcome these hurdles. EMWA is very much aware of these challenges, as addressed…

Pharmacovigilance - Volume 31, Issue

The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Rush to publication – What do we have to lose? - Volume 29, Issue

Just as the research and development of new drugs requires careful, often painstaking, adherence to empirical processes, the peer-review process and, indeed, the manuscript preparation process, are likewise laborious and time-consuming. The benefits…

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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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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