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The use of machine translation and AI in medical translation: pros and cons - Volume 33, Issue

In this article, I provide a retrospective look at the emergence of translation technologies and summarise the pros and cons of the use of neural machine translation and generative AI tools in medical translation. I will examine both the advantages…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…

Pharmacovigilance for vaccines and immunotherapies - Volume 27, Issue

Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…

In vitro plants: How to open a jar containing bioactive phytochemicals - Volume 32, Issue

Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…

Subcontracting: Not for the faint of heart - Volume 28, Issue

Subcontracting can be the answer to a successful freelancer’s prayers, or the opportunity to work harder than you have ever worked before for less money than you made when you were a struggling newbie. The potential advantages of subcontracting are…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…

Sluggish downloads, lagging video calls: Tips for the remote worker to tame technology - Volume 31, Issue

What are the various broadband options to consider when working from home and how can you ensure you’re getting the best from yours? Broadband failures can mean a headache for your clients and you risk looking unprofessional, so having a backup…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective - Volume 32, Issue

Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

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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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