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The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
Making the first steps as a medical writer in the pharma and biotech industry can be challenging. Three general principles can help managers foster the growth and development of their team members: Reveal, Rebalance, and Release. Reveal means that…
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…
Copyediting is crucial for enhancing the quality and credibility of medical manuscripts in Pakistan. Although English is an official language used in government and education, many researchers are not native speakers, leading to linguistic inaccuraci…
Mentorship is an extremely rewarding relationship between two people with the goal of professional and personal development. Elemed’s Mentoring Academy in partnership with the Regulatory Affairs Professional Society (RAPS) combines three pillars –…
Medical devices should certainly be included on any list of trends in medical writing. That impression was only reinforced by the strong interest in device writing evident at this year’s EMWA spring conference. The three medical device workshops on…
Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…
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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Alicia Brooks Waltman
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Gained in Translation
Getting Your Foot in the Door
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Pablo Izquierdo / Alison McIntosh
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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