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From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…
Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…
This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…
I can't believe that my two years on the Executive Committee are now complete – what a journey from Manchester and Barcelona in 2013, Budapest and Florence in 2014, and finally Dublin in 2015. Apart from travelling many miles, I have had a great…
The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…
In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
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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