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Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…

Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry - Volume 32, Issue

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…

Five questions for Ruggero Galici on nonclinical medical writing - Volume 32, Issue

Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…

The COVID-19 pandemic as a catalyst for digitalisation and remote working in Germany - Volume 31, Issue

Remote working is ideal for medical writers, but up until a few years ago, was not widely available to those looking for a remote position with a German employer. Even though Germany is a developed country, its digitalisation has long been lagging,…

Interview with Professor Matthias Rose on developing patient-reported outcomes and the PROMIS initiative - Volume 27, Issue

Professor Matthias Rose is Medical Director of the Psychosomatic Department at the Charité University Hospital in Berlin, Germany. In this interview, I discuss with him patient-reported outcomes and the Patient-Reported Outcomes Measurement…

Lay writing: Strategies for improving assent forms - Volume 27, Issue

Writing for lay audiences is recognised as a difficult task for medical writers, whose specialised knowledge can often hinder effective lay communication. This task is even more challenging when preparing clinical trial information for a…

Digital Communication - Volume 30, Issue

Digital communication – bringing us closer Digital or online communication is second nature to us all – with more than half of the global population active on the internet, a world without it seems unimaginable. In recent years, digital…

Medical writing for cancer trials and submissions - Volume 21, Issue

Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…

Thirty-seventh EMWA Conference, 7–9 November 2013, Barcelona, Spain - Volume 22, Issue

EMWA's 37th Conference will be held at the Fira Palace Hotel in Barcelona from Thursday, 7 November to Saturday, 9 November 2013. The Fira Palace Hotel is ideally situated in the trade-fair and exhibition area and is a short walk from Barcelona's…

Out On Our Own - Volume 22, Issue

The EMWA autumn conference is always so well placed in November, giving us the chance to meet friends and colleagues before the onslaught of traditional end of year festivities. Barcelona's conference was no exception. We were pleased to welcome new …

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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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