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Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…
This edition of Veterinary Medical Writing signals a changing of the guard as Karim Montasser passes on the reins, having guided this section of Medical Writing with a steady hand during his tenure. And it is mindful of those auspicious shoes to…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…
February 26, 2021 – EMA has recommended granting a marketing authorisation in the European Union (EU) for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic…
The one sentence summary of a paper signed by 72 statisticians was: “We propose to change the default P-value threshold for statistical signifi - cance for claims of new discoveries from 0.05 to 0.005”.1 The proposal is straightforward, but it must…
Dear EMWA Members, Our Munich 2016 Spring conference was a great success that showcased a mature association leading on important topical issues. EMWA’s outward looking perspective developed over the past couple of years is the focus of my final…
May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…
Abstract Transparency has been an objective in the pharma world in recent years, culminating in the recent decision by the EMA to release full clinical study reports into the public domain. In spite of the publicity surrounding transparency and data…
Before one can get one’s foot in the door, one needs to be aware that there is actually a doorway. This is the mission of the EMWA Ambassador’s Programme – to inform the world about medical writing as a career path. In other words, we set up signs…
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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