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Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…
Critical thinking is necessary to edit a scientific article. However, in addition to questions about the language, we can also question the assumptions, documentation, and implications of the research, in a process I call “analytical editing.” A…
Anyone working in pharmacovigilance (PV) will already have spent many months working their way through the ever changing updates and reforms to the Risk Management Plan (RMP), and the newly legislated RMP summary. Those not working in PV will…
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…
Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated…
Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…
This issue of Medical Writing focuses on authors and authorship, but where, in fact, did the term “authorship” come from? The term first appeared in the early 18th century. In a paper presented at the Annual Meeting of the National Council of…
As patients are increasingly involved in healthcare decisions, there is a growing need for them to have access to appropriate health information. Medical writers, being a link between medical research and published data, are well placed to make…
Since January 2015, EMWA has held a number of webinars on different topics. The most recent EMWA webinar was presented by Helen Baldwin on 25 June 2015 and was entitled ‘What you always wanted to know about medical writing - but never dared to ask’.…
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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