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Welcome to Getting Your Foot in the Door or GYFD for short, the latest addition to MEW’s regular sections. It all started at the EMWA 2015 autumn meeting in The Hague. Derek Ho met up with the EMWA Executive Committee (EC) to talk about his idea of…
In the apparently quiet time after the spring conference in Barcelona, much has been going on in the background of the association’s life. Before moving to the details of our activities, I would like to mention that two veteran members of the Head…
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
How to make our life easier? It was my pleasure to invite my colleagues from the European Association of Science Editors (EASE) to share their editorial experience with us medical writers. By doing this, we can improve our writing, which will…
When I was asked to write about using social media for work and collaboration, one “professional” social media platform immediately sprang to mind – LinkedIn. This article discusses LinkedIn, one of many social media platforms in a prosperous…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…
Building knowledge and capacity for patients and their advocates about the “systems” of healthcare is empowering for patients. The European Patients’ Academy (EUPATI) was established across Europe in 2012 to provide education and training to…
Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…
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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