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Calling all medical writers:
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In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…
Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of…
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.…
Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…
Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…
Meeting reports are an aspect of ‘medical’ and other technical writing that has had little discussion. The following might be of interest to medical writers asked to provide rapid, reliable, objective reports of various types of meeting. The United…
The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…
The use of artificial intelligence (AI) writing assistants in the healthcare industry is becoming increasingly prevalent. These tools can help medical writers to generate content more quickly and efficiently, but they also raise concerns about the…
Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…
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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