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The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…
Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…
VUCA stands for volatility, uncertainty, complexity, and ambiguity. The healthcare sector is considered a VUCA industry, constantly changing through rampant mergers and acquisitions, rapidly evolving regulations, and leading-edge innovations. So how…
Implantable medical devices (IMDs) have restored viable and meaningful lives to millions of people who would have otherwise continued to be severely restricted or suffered early death due to their pathologies. Research and development of IMDs are…
The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…
Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…
Pharma-Brexit is on its way. The announcement of the European Medicine Agency’s move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions…
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…
During a visit to Greece more than 15 years ago when I was involved in an animal protection campaign, I met a journalist who was investi gating prohibited fishing methods that local fishermen were using. When he was asked by the animal protection…
The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
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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