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Crafting a sustainable freelance MedComms career can be challenging. As freelancers, we need to understand our individual requirements to design and implement a freelance business that will work from a personal and a professional perspective.…
The thalidomide tragedy of the early 1960s cost several thousand lives, but it ultimately led to changes that will undoubtedly save many thousands more: it triggered a chain of events involving the WHO and the ICH that resulted in the…
HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…
Freelancing offers an ideal way of making a living for many of us, providing the opportunity to work from home, and be our own boss. However, working for yourself comes with its own set of challenges and is definitely not an easy option. Success is…
An Introduction to Pharmac - ovigilance is a compelling read and one that both new and experienced medical writers will find useful for providing a suc - cinct, yet thorough, overview of today’s current drug safety requirements. Patrick Waller and…
Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…
Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…
On July 29, EMWA, together with the American Medical Writers Association (AMWA) and the International Society for Medical Publication Professionals (ISMPP), issued a joint position statement on the dangers of predatory publishing (see p. 34 of this…
With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity areincreasingly publicly available, it…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
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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