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The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…
The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…
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)…
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…
We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…
Artificial Intelligence (AI) and machine learning-driven software are evolving toward a technological advancement revolutionising the current global, social, and economic landscape. A major breakthrough in AI is the fast-growing natural language…
Writing matters to medical writers … or at least it should. But sometimes we are more consumed with the content of a document than the writing itself. And some might even argue that detailed medical or scientific information cannot be written as…
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…
All of us are aware by now that we can't live without technology and not only at work. With advice, aids, appliances and apps in abundance, we are at the point where we can't see the wood for the trees. Thank goodness we have advice from M…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
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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Victoria White
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