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Within Portugal, medical writing is a new and rare profession. We describe our personal career routes to medical writing and discuss the barriers and the emerging opportunities for medical writers in Portugal. The profession of medical writing is…
This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…
Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…
The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…
Mentorship is an extremely rewarding relationship between two people with the goal of professional and personal development. Elemed’s Mentoring Academy in partnership with the Regulatory Affairs Professional Society (RAPS) combines three pillars –…
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…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
Doughnut economics provides a new framework for sustainable development, by balancing the ecological boundaries of the planet with the social boundaries of humanity. The framework provides a valuable opportunity for the healthcare industry to…
CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…
Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…
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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