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With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
This article gives an overview of the request for proposal (RFP) process, which can often be challenging for those new to medical communications. Four key areas are outlined: understanding the RFP process, teamwork, the pitch process, and seeking…
EMWA team responds to ICMJE requirements on sharing clinical trial data In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…
Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in…
Mentoring may be valuable to today’s students who are considering their future career options in an increasingly competitive, demanding, and challenging world. This article outlines the author’s experience of mentoring tomorrow’s medical writers,…
Dear colleagues, friends, and EMWA members,Happy 30th EMWA anniversary!We have an exciting new year ahead of us. To celebrate EMWA’s 30th anniversary, we will take a deep dive into EMWA’s history, celebrate our present accomplishments, and aim to…
Oncology is one of the most common areas of drug development in the pharmaceutical industry. As a medical writer, it is important to be aware of the unique aspects of oncology studies and have some understanding of the principles underlying cancer…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…
It is my real pleasure to welcome you to the second issue of Lingua Franca and Beyond, a regular feature of Medical Writing for non-native English speaking medical writers. As soon as I'd written those words, I realised that this section should not…
More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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AI/Automation
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In the Bookstores
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My First Medical Writing
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Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
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Chris Monk