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Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…
Welcome to The Light Stuff One of the unwritten laws of EMWA is ‘Never talk to the editor of the journal if you don't want to end up working on it in your spare time’. I can joke about this because as I was the editor of the EMWA journal from 1998…
Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…
Our gathering in Budapest last month was, as always, fun and this time a little different. We welcomed you to a new-look Freelance Business Forum (FBF) after polling you in February on what you hoped to gain from FBF attendance and your preferred…
Section Editor: Adriana Rocha Navigating my freelance journey while driving EMWA freelance activities Author: Laura A. Kehoe I didn’t plan to become a medical writer, but then again who does? It wasn’t, at the time, a career on the list of things…
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…
The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…
Want to learn more about medical device regulations? Then read some of the presentations held at EMWA’s medical device symposium this year: https://www.emwa.org/conferences/emwa-symposia/.
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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Alicia Brooks Waltman
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