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Position Statement - AMWA-EMWA-ISMP Joint Position Statement on Medical Publications, Preprints, and Peer Review - Volume 30, Issue

In medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and time-consuming process of the…

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…

Medical Communications - Volume 26, Issue

Dear all,The legal side of our job is something that most of us usually give little thought to. We assume that as scientists, we are automatically on the “right side” and therefore pretty bulletproof. Why should the law affect us, as longas we have…

Good regulatory practice and the role(s) of a regulatory affairs professional - Volume 22, Issue

Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles…

Mentor vs. line manager: Differences and similarities - Volume 30, Issue

A good mentor may be a good line manager in a business setting and vice versa, but there are some key differences: mentors are more skill-oriented, while line managers are more goal-oriented. People who are both good line managers and mentors are…

Incoming President's Message - Volume 31, Issue

Dear EMWA friends and colleagues, as I draft this message, we are coming to the close of EMWA’s 53rd conference in Berlin, Germany. By all measures, it was a great conference with almost 400 delegates participating in our full programme…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

The evolving landscape of medical education in oncology - Volume 21, Issue

The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…

The Webscout - Volume 24, Issue

When thinking about the topic of this issue I questioned why for some people business is a source of fun while for others it is not. We all know that factors like time pressure, an inadequate working environment and a lack of variety in our tasks…

EU software regulations: The new normal or innovation stagnation? - Volume 29, Issue

Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…

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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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