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A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…
The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…
It’s autumn again and most of you will have returned from your vacations by now reenergised and ready for the year ahead. The Executive Committee has been busy planning our conference in Cascais scheduled for November 2–4. We are planning to hold 29…
Systematic literature reviews are an essential component of the medical device clinical evaluation process. The EU Medical Device Regulation requirement for regularly updated systematic literature searches will increase the burden on the medical…
The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…
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…
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…
Clear communication with the public and with potential clinical trial participants and their caregivers is foundational to the ethical tenets of respect, justice, and beneficence. However, health literacy, even of highly educated individuals, often…
The medical profession has a well-deserved reputation for atrocious handwriting, which has undoubtedly led to many mishaps in patient care. Sometimes, however, problems in interpreting doctor's writing, as those of us who have worked on publications…
The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the…
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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