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In the Bookstores - Volume 27, Issue

An Introduction to Pharmac - ovigilance is a compelling read and one that both new and experienced medical writers will find useful for providing a suc - cinct, yet thorough, overview of today’s current drug safety requirements. Patrick Waller and…

News from the EMA - Volume 30, Issue

Medical writers at EMA have published an “EMA medical terms simplifier” (https://www.ema.europa.eu/en/documents/ot her/ema-medical-terms-simplifier_ en.pdf) on the “Glossaries” page of EMA’s website (under “About us”) to provide public-friendly…

Ins and outs of environmental risk assessments (ERA) of medicinal products for human use - Volume 31, Issue

An environmental risk assessment (ERA) is the process of evaluating the effects of drugs for human use on the environment. ERAs must accompany all new drug market authorisations in Europe. In this article, we discuss the current guidelines on ERAs…

Blockchain in healthcare, research, and scientific publishing - Volume 28, Issue

Data are being transmitted and stored on cloud-based networks, including clinical, research, and publishing data. These cloudbased systems often lack comprehensiveness, accessibility, interoperability, confidentiality,accountability, and…

Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

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…

The perils of the unknown: Missing data in clinical studies - Volume 27, Issue

The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

Out on Our Own - Volume 26, Issue

Greetings, readers.For freelancers, receiving feedback is an important process for building a mutually productive relationship with a client. Positive feedback serves to encourage and helps develop core strengths, while constructive criticism is…

Comics aren't just for kids: Using cartoons in medical communications - Volume 30, Issue

Comics aren’t just for kids. They’re a provo - cative, entertaining, and storytelling medium powerful enough to captivate people of all ages, all languages, and all cultures – no small feat in today’s era of instant gratification. To engage our…

Preventing biomedical research waste - Volume 31, Issue

An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…

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Scope

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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