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Manuscript Writing - Volume 21, Issue

What are the most common reasons for a manuscript to be rejected (and how can they be avoided)? In their article on handling manuscript rejection, Woolley and Barron1 offer the following soothing advice: Authors, particularly inexperienced…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

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…

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

Study design made easy - Volume 25, Issue

Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…

The Webscout - Volume 24, Issue

‘A ship is safe in a harbor – but this is not what ships are made for’. (William G.T. Shedd, American theologian, 1820–1894) Risky scenarios are something many people try to avoid. But you will find yourself in situations when you have to face…

Getting Your Foot in the Door - Volume 32, Issue

Editorial Ivan Turek (section editor) Medical Writing. 2023;32(3):91. The hitchhiker’s guide to the EMWA conference: Reflections and recommendations from first-time delegates Anna Isermann, Louisa Ludwig-Begall (authors) “The story so far: In…

Preparing the Paediatric Investigation Plan application - Volume 21, Issue

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…

Did minor flaws in a new drug reveal major flaws in company publication practices? - Volume 23, Issue

Pradaxa, a new drug for the treatment of blood clots, has been revealed to produce some negative side effects on a minor population of patients, according to a new study. However, the road leading to the publication of this study revealed that…

Medical Journalism - Volume 22, Issue

From science writing to journalism: How ‘The Ghost Writer’ changed my life. How can a medical writer become a science journalist? That is the question I was asked to answer in an article inaugurating the Medical Journalism column of Medical…

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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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