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Quality of life measures – an overview - Volume 27, Issue

HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…

A picture is worth a thousand words - Volume 29, Issue

As modern medical writers, we face a changing communication landscape greatly altered by the arrival of the internet and the rise of social media. This article provides insights on how to keep pace and what options you have to make your…

News from the EMA - Volume 23, Issue

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…

Getting more out of PowerPoint® - Volume 23, Issue

PowerPoint® is unavoidable in today's society. It is equally loved and hated. Although it is ubiquitous, many users of the program fail to understand why their presentations are not achieving the desired effects. The answer to this lies in part…

The PROMIS of electronic patient-reported outcomes - Volume 27, Issue

Paper-based questionnaires are in widespread use for patient-reported outcomes, but they can be an inefficient way of collecting patient data. Electronic patient-reported outcomes are of wide interest and have the potential to drastically change…

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…

Clinical data publication by the EMA: The challenges facing the pharmaceutical industry - Volume 27, Issue

As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised…

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…

A primer on anonymisation - Volume 28, Issue

Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…

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…

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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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