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Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…
The fourth EMWA freelance business survey Introduction This fourth survey follows those conducted in 2003, 2007, and 2010.1–3 The first survey was conducted with a paper questionnaire distributed to both freelancers and small businesses…
Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
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…
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…
Writing for lay audiences, especially lay summaries, is needed to increase health and science literacy, but this kind of writing can be difficult for scientists. The article describes why it can be so difficult and gives some advice on how…
I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…
Involving patients in decisions about their care attracts wide support in theory, but making it happen in practice has proven quite difficult. Embracing shared decision-making with patients will be more important than ever when healthcare…
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…
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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