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AI language models are transforming the medical writing space – like it or not! - Volume 32, Issue

Whether you’re an early adopter, an occasional user, or yet to acknowledge its transformative potential, artificial intelligence (AI) – specifically generative AI applications underpinned by large language models – is undeniably shaping our present…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

In the Bookstores - Volume 22, Issue

This book is regarded by many as the holy grail of reference manuals. For those not familiar with the great tome it contains a massive amount of information regarding ‘publication style and format for scientific papers, journal articles, books, and…

Regulatory Public Disclosure - Volume 28, Issue

EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to…

Global HTA: Past, present, and future - Volume 30, Issue

Health technology assessment (HTA) is a relatively recent innovation that has changed the way decisions are made in healthcare. It is a multidisciplinary process that requires different skill sets and collaboration among various disciplines and…

The Webscout - Volume 21, Issue

Diabetes and Psychology You all may know that diabetes is a metabolic disease leading to secondary micro- and macrovascular complications, like nephropathy, neuropathy, and cardiovascular diseases. You may also know that these microvascular…

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…

Editorial - Volume 27, Issue

A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.

Educating the medical writer: A 5-year update - Volume 28, Issue

This article is a 5-year follow-up to a 2013 publication: On Educating the Medical Writer. The current study was performed to examine the evolution of degree programme titles, certificate programmes, and the current trend toward so-called…

Regulatory Matters - Volume 30, Issue

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

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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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