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The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…

Paragraphing (Part 1 of 2) - Volume 21, Issue

The purpose of paragraphing is to make text understandable and easy to read, and to help you tell your story effectively. Paragraphing is difficult because the purpose of the documents we produce and their readership are diverse. To make matters…

A rising tide: Hospitals and social media - Volume 21, Issue

The advent of social media has changed the face of healthcare communications. More and more hospitals are recognizing this fact and seeking to integrate tools like Twitter® and Facebook® into their own communications strategies. This article gives…

Growing the top and bottom line of your mind – an entrepreneurial journey as a joint venture with mentors - Volume 30, Issue

Having spent more than a decade in academia, it has been almost inherent to me to think of learning as exercising your IQ, thereby improving you practical and technical knowledge. It is quantifiable and can easily be described on your CV. The mentor…

A wonderful "Medium" for medical writers - Volume 30, Issue

With the advent of social media platforms and the increasing availability and access of information on the internet, we are not limited by information sources on any subject. Medium.com, since its inception in 2012, has become a very good blogging…

Preclinical studies - Volume 26, Issue

Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many…

Medical writing around the world - Volume 22, Issue

As many of you are already familiar, Medical Writing began as The Write Stuff, a publication written by and for EMWA members. One of the goals in making the transition to Medical Writing was that it would become an international journal with readers…

Passing the Torch: The Sequel/Filling Big Shoes - Volume 29, Issue

For the last 8 years, I have been serving as Editor-in-Chief of Medical Writing. I feel that it’s time to pass the torch to a new person with new energy and fresh ideas. As I wrote in 2012, “This is yet another step in the evolution of the…

Out On Our Own - Volume 23, Issue

Our gathering in Budapest last month was, as always, fun and this time a little different. We welcomed you to a new-look Freelance Business Forum (FBF) after polling you in February on what you hoped to gain from FBF attendance and your preferred…

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

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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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