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The new value of clinical data in Europe - Volume 29, Issue

The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…

Now more than ever, scientists must speak up for science - Volume 28, Issue

In this post-truth era we live in, the validity of facts from climate change and evolution to the shape of the earth and even vaccine safety is challenged by misinformation. As scientists,we should make greater efforts to engage with the public and…

Layperson materials in the sphere of biosimilars and generic medicines - Volume 28, Issue

Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…

EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans - Volume 26, Issue

Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…

In the Bookstores - Volume 22, Issue

Bad Pharma is the latest book by the well-known anti-quackery campaigner Ben Goldacre, and attempts to explain to us that medicine is broken. Despite the title, he criticises not only the pharmaceutical industry, but also regulators, doctors,…

Regulatory Matters - Volume 25, Issue

The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…

Medical Devices - Volume 29, Issue

The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…

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…

Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Speaking your patients’ language – Is it really worth it? The impact of translation on multilingual patient education materials - Volume 33, Issue

This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…

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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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