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From the Editor - EMWA and Medical Writing: 12 months into the pandemic - Volume 30, Issue

What a year! A year of corona, crisis, and challenges. But also a year of innovations, break - throughs, and opportunities. I am one to focus on silver linings and here are some to think about. I am immensely proud of being part of an industry that…

Collecting metrics in medical writing – the benefits to you and your business - Volume 28, Issue

Collecting and using metrics may not be at the forefront of all medical writers’ minds, but they can be an important asset to writers and managers, from freelancers to those working within companies, large or small. Keeping a record of pertinent…

Good Writing Practice - Volume 28, Issue

Paragraph lengthiness and complexity cause a continuity inexplicity (discontinuity), which can be lessened by using forecasting and backcasting markers of the information pattern. Thus, omission of such continuity markers (e.g., a subheading)…

HIV research fraudster handed stiff prison sentence - Volume 24, Issue

In the December 2014 issue of Medical Writing, I reported that disgraced Iowa State University researcher Dong-Pyou Han was facing fraud charges for faking experiments on a new HIV vaccine.1 In spite of a guilty plea, on 1 July 2015 Dr Han was…

The role of real-world evidence in post-market clinical follow-up - Volume 34, Issue

Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements, methodologies, and…

Expanding the safety horizon: How real-world evidence shapes drug safety - Volume 34, Issue

Real-world evidence (RWE), generated from real-world data (RWD), is pivotal in evaluating the safety and effectiveness of medical treatments beyond the controlled settings of clinical trials. Unlike randomised controlled trials (RCTs), which often in…

Lingua Franca and Beyond - Volume 25, Issue

Communication, communication and even medical communication What is it about? Let’s start with the Wikipedia definition: “Communication (from Latin comm - ūnicāre, meaning ‘to share’) is the purposeful activity of information exchange between two…

Building resilience: Navigating challenges and thriving among the demands of regulatory writing - Volume 33, Issue

Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…

News from the EMA - Volume 26, Issue

Conditional marketing authorisations give patients access to important new medicines earlier January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union…

Veterinary sustainability - Volume 31, Issue

Respected for their knowledge of animal health and disease, veterinarians safeguard animal health and welfare and, where applicable, the productivity of animals under their care. With the threats posed by climate change, the veterinary profession…

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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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