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Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

How and why it works: The principles and history behind visual communication - Volume 29, Issue

"“A picture is worth a thousand words” – a familiar adage, and the reason why newspaper articles are commonly accompanied by photographs and infographics. Scientific publications are no different, so medical writers are frequently asked to…

Profile: An Interview with Michael Markie - an open science and open data advocate - Volume 26, Issue

Medical writers commonly are hired to write for traditional journals targeting the highest possible impact factor. However, as medical writers, we should be aware of alternative options. In September last year, I had the pleasure to meet Michael…

The perils of the unknown: Missing data in clinical studies - Volume 27, Issue

The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…

Leveraging infographics in study schemas - Volume 29, Issue

Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…

Out On Our Own - Volume 21, Issue

Another summer has come and gone. In this issue of OOOO, we are happy to feature Paul Woolley's novel approach of comparing employment and freelancing. I am sure many of us can identify with some of the points he raises. We thank Debbie Jordan for…

The new PubMed – underestimated regulatory obstacles - Volume 29, Issue

NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…

EMWA news - Volume 21, Issue

News from the EMWA Website Manager New role At the recent EMWA conference held in Cyprus, I assumed the position of EMWA Website Manager. While this is a daunting task, it is a challenge I am pleased to take on. To ensure that I was in a…

Social media scheduling: How not to spam your followers - Volume 30, Issue

Social media is, today, an indispensable part of networking and business. However, many professionals are still learning how to navigate the sea of social media. Big companies have a dedicated department, but small businesses, entrepreneurs, and…

Getting Your Foot in the Door - Volume 27, Issue

One of the most challenging questions faced by academic life scientists at some point in their career is whether to pursue research or to look for suitable positions within industry. While the shift from academia to industry might result from a…

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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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