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How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…

Introduction - Volume 28, Issue

It is my privilege to present you the Medical Writing special issue garnering the current Trends in the Medical Writing sphere. With the perpetual amendments in the pharmaceutical industry and the ever-evolving approaches in operating and…

President’s Message - Volume 33, Issue

Welcome to the latest issue of Medical Writing. Following our record-breaking Spring conference in Valencia, Spain, which saw an unprecedented number of attendees, I am both humbled and excited to address you as the new President of EMWA. The…

Profile: An Interview with Michael Markie - an open science and open data advocate - Volume 26, Issue

Medical writers commonly are hired to write for traditional journals targeting the highest possible impact factor. However, as medical writers, we should be aware of alternative options. In September last year, I had the pleasure to meet Michael…

Clinical Evaluation Reports from the medical writer’s perspective! - Volume 26, Issue

Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…

Someone in your corner: Musings of a mentor and mentee - Volume 30, Issue

What is a modern mentorship, how do you make it work, and what does gardening have to do with it? Let us take you on a tour of the growing garden of our own modern mentorship, showing how we as a medical writer (Lillian Sandø; mentor) and a clinical…

Implications of clinical trial data sharing for medical writers - Volume 22, Issue

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…

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…

Medical Device Regulation: A necessary step towards more patient and user safety - Volume 26, Issue

Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…

The Crofter: Sustainable Communications - Volume 31, Issue

Greeting from the croft! During my non-linear career path, there has been one recurring theme that always rang true: “Context matters”. As a physical therapist working in a rehabilitation centre, understanding my clients’ social roles, home…

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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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