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We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
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…
Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…
In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…
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…
Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…
The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…
The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers predominantly working in industry or for agencies to learn of their personal and professional…
Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…
In our post-truth era of media and communications, implementing a sound content strategy can help your message reach the right individuals. It is time for experts and healthcare companies to lead the change as ethical and credible sources of…
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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