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Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

My First Medical Writing - Volume 28, Issue

In this release of My First Medical Writing, we welcome one of the first articles written by Robin Sachdeva. Robin finished his PhD at Heidelberg University in Germany, and he is passionate about reading and writing about diabetes. Fortunately,…

Making medical communication accessible to all: A translator’s perspective - Volume 34, Issue

Language barriers in healthcare can put patients at risk, leading to misdiagnoses, delays in treatment, and exclusion from clinical trials. Clear communication requires cultural adaptation to ensure patients understand and trust the information they…

Registration and ethics committee approval for observational studies: Current status and way forward - Volume 26, Issue

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…

Gained in Translation - Volume 25, Issue

Welcome to the Translation Section editorial! The Italian word Itangliano means Italian that is very much influenced by the English language and most of all it refers to the great presence of English words that are not adapted into Italian.…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Immuno-oncology: Harnessing our immune system to fight cancer - Volume 27, Issue

The history of immunotherapy to treat cancer began in 1891 when the American surgeon William Coley performed intra-tumoural injections with inactivated bacteria in patients with advanced sarcoma, in an attempt to stimulate anti-tumour immunity.…

Social media and altmetrics: The pharma perspective - Volume 30, Issue

The increased prevalence of healthcare-related social media and other web-based communications has generated interest in tools that measure the attention and engagement of published content. In the context of medical research publications, the use…

Authorship of clinical trial documents - Volume 25, Issue

Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…

President’s Message - Volume 30, Issue

It fills me with sadness that we had to cancel our spring face-to-face (F2F) conference in Riga. It’s been 1 ½ years since our last in-person meeting! Yet we hope that we at least will have the chance to meet in Cascais this autumn. But I also have…

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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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