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The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
Reviews provide a synthesis of published literature on a topic and describe its current state-of-art. Reviews in clinical research are thus useful when designing studies or developing practice guidelines. The two standard types of reviews are (a)…
Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…
Patient-reported outcomes (PROs) are an essential element to demonstrate the value of a health intervention. In many ways, PROs represent the ultimate “real-world” data, yet the drive towards “Big Data” has focused onroutinely collected data from…
Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…
This is the first Medical Writing Biotechnology regular section. Biotechnology is a broad subject. It can be defined by the use of biological systems and living organisms in production processes. Biotechnology has been around for thousands of years.…
Ahmad Nazzal defines biotechnology as, “a field of science that involves using living organisms and organic substances to create or modify environments, produce goods, or improve human health.” Biotechnology is a vast topic and can be defined by…
Ambassadors Programme News The EMWA Ambassadors Programme is continuing its efforts to reach out to new audiences to promote medical writing and EMWA. Marie Kołtowska-Häggström gave a talk (in Polish) on medical writing as a profession at the…
We invited EMWA members to report on the medical device symposium and selected Expert Seminars during the spring conference in Barcelona, held in May 2018. We hope that this initiative will help to keep EMWA members up to date with our fast changing…
We invited EMWA members to report on the medical device symposium and selected Expert Seminars during the spring conference in Barcelona, held in May 2018. We hope that this initiative will help to keep EMWA members up to date with our fast changing…
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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