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Conditional marketing authorisations give patients access to important new medicines earlier January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union…
In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
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…
Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
After a wonderful May spring week in sunny Cyprus – it was good to see so many of you at the Freelance Business Forum (FBF) – it's back to business as usual with a packed issue. The FBF minutes summary has not made it into this issue due to print…
Greetings, readers.In this issue of OOOO, we start off with an important question – how do I prevent the risk of working too much? An apt question as we approach the end of the year, finishing up our projects and settling in to enjoy the holiday…
I'm sitting down to write this having just returned from the DIA Euro meeting in Amsterdam. As always, it was a busy and successful meeting, with many ‘themes’ of presentations being given at once. However, this year there were many presentations…
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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