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The participant information sheet (PIS) is one of the documents that promote most discussion and concern for research ethics committees (REC). This article looks at ways to ensure the PIS meets their requirements based on the specific experience of…
Many regulatory medical writers start their careers in pharma. Whilst many continue in pharma, some also work in medical devices and an increasing number are switching to medical device writing. This article explores how and why writers might move…
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…
We are living in an era of data deluge. With the amount of data generated increasing rapidly, organisations are in high need of individuals who are skilled at managing, analysing, and interpreting data. Data literacy is deemed as a crucial…
In this release of My First Medical Writing, I have the pleasure to share with you a great article written by aspiring medical writer Shirene Melissa Singh. With over 5 years of experience as a university educator and researcher, she is passionate…
Medical translation training around Europe It’s been said a thousand times, yet, many are still not fully aware of the importance that translation has in our daily lives. Rather than merely supplanting one form of words with another, the translator…
After the debut of the first edition of this section, I was honoured to be contacted by many aspiring medical writers eager to contribute and to showcase their writing skills. Among them, Matías Rey-Carrizo did anamazing job in translating a complex…
Preparing clear, convincing scientific manuscripts is a challenge. In my experience, the biggest problem for most writers is not an inability to write well in English but rather a lack of clarity regarding what their article is supposed to be about.…
Having spent more than a decade in academia, it has been almost inherent to me to think of learning as exercising your IQ, thereby improving you practical and technical knowledge. It is quantifiable and can easily be described on your CV. The mentor…
How to make our life easier? It was my pleasure to invite my colleagues from the European Association of Science Editors (EASE) to share their editorial experience with us medical writers. By doing this, we can improve our writing, which will…
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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