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Dear colleagues Time really does fly when you're having fun: I'm writing my third message since becoming EMWA President in May! The 37th EMWA Conference in Barcelona was an exciting event in a great location. We welcomed 102 new members, and 240…
‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…
Taking a step back to understand the history of clinical trial regulation triggers a broader perspective on the work we do or the work we will do. As regulatory medical writers, our role is often limited to the more technicalsubmission-level…
In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…
The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…
Clinical trial transparency is beneficial for patients, researchers, and the general public. However, rapidly evolving regulatory requirements for transparency have increased the information that will be published. Medical writers can play a key…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…
Increasing amounts of information are being made available to patients – but how do we know if we are getting it right and meeting people's needs? In this article, we describe how we have employed user testing to test and improve not just…
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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