Your search for "regulation" matched 503 page(s).
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Just as the research and development of new drugs requires careful, often painstaking, adherence to empirical processes, the peer-review process and, indeed, the manuscript preparation process, are likewise laborious and time-consuming. The benefits…
Medical advisory board meetings are anintegral part of the healthcare and, inparticular, the pharmaceutical landscape.These meetings serve to identify knowledgegaps in a specific therapeutic area and tosuggest measures that could be implementedand…
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…
Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…
A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply of providers. The challenge that arises in such a…
Regulatory documents are prepared in a highly collaborative process within tight timelines. The time and the resources required for collecting input, organising document review, and processing the reviewers’ responses often dwarf those invested in…
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…
Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…
The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…
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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