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In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

In the Bookstores - Volume 23, Issue

Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare by Peter Gøtzsche; Radcliffe Publishing, 2013. ISBN: 978-184619-884-7 (paperback). 24.99 GBP. 310 pages. Mastering Scientific and Medical Writing: A Self-help Guide by…

Regulatory Matters - Volume 26, Issue

Brexit and the European Medicines Agency The British government has formally triggered Article 50, setting in motion Brexit and negotiations can begin in earnest. If before, politicians could gloss over the complexities, they are now obliged to…

The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday - Volume 27, Issue

Pharma-Brexit is on its way. The announcement of the European Medicine Agency’s move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions…

Profile: An interview with Professor Peter Jüni on methodology and statistics in scientific manuscripts - Volume 25, Issue

This issue of Medical Writing (MEW) is about statistics, so what is more appropriate than interviewing a research methodologist who focuses on epidemiology and statistics in clinical research? I am happy that we were able to win Professor Peter Jüni…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

The changing face of (benefit-)risk management - Volume 24, Issue

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…

News from the EMA - Volume 28, Issue

October 5, 2018 and November 16, 2018 – Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Grampositive classes. EMA’s Pharmacovigilance Risk Assessment Committee…

News from the EMA - Volume 31, Issue

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…

Gained in Translation - Volume 24, Issue

We often write articles to satisfy two states of mind: pleasure and curiosity. In my case, this means the curiosity to delve into some of the intricacies of translation on the one hand, and, on the other, the desire to work together with colleagues…

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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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