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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…

Project management in medical publication writing: A less explored avenue in pharmaceutical companies and clinical research organisations - Volume 25, Issue

Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…

Sunshine spreading across the Atlantic and over Europe - Volume 22, Issue

The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…

The Big Pharma conspiracy theory - Volume 22, Issue

This essay outlines the broad themes of the conspiracy theory that pharmaceutical companies, regulators, politicians, and others are secretly working in consort against the public interest. This so-called Big Pharma conspiracy theory shares a number…

Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations - Volume 25, Issue

The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers predominantly working in industry or for agencies to learn of their personal and professional…

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…

Medical writing in India at a crossroads - Volume 22, Issue

Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

Editorial: Pharmaism - Volume 22, Issue

Criticising the pharmaceutical industry is a type of sport, and it is astonishing what nonsense people will believe about it. For example, it has been said that pharmaceutical companies will only conduct a clinical trial against another product that…

On the western edge of Europe – medical writing in Portugal - Volume 22, Issue

Within Portugal, medical writing is a new and rare profession. We describe our personal career routes to medical writing and discuss the barriers and the emerging opportunities for medical writers in Portugal. The profession of medical writing is…

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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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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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