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Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…
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…
The transition out of academia can involve a good deal of change. For PhDs who enjoy writing, a career in medical communications is a viable option. The field of medical writing is broad, encompassing everything from regulatory affairs, to writing…
The career choice is an unavoidable topic for those scientific graduates or experienced professionals in the areas of medicines or the pharmaceutical industry. The career of medical writing offers a series of career possibilities for the individuals…
Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…
The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…
Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…
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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