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Do you know the difference between compliment and complement? Do you know your breeches from your breaches? Do you know why the word ‘Ghoti’ should be pronounced ‘fish’? Answers to these questions and many other interesting facts regarding the…
The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…
Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…
The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…
Professor Matthias Rose is Medical Director of the Psychosomatic Department at the Charité University Hospital in Berlin, Germany. In this interview, I discuss with him patient-reported outcomes and the Patient-Reported Outcomes Measurement…
Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators…
In this edition of GYFD, EMWA Internship Forum (IF) lead Derek Ho gives us a rundown on the second Live IF in Birmingham. Don’t forget – Barcelona is the next IF venue! The second contribution is from Laura Rodriguez. Laura is not a medical writer…
Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare by Peter Gøtzsche; Radcliffe Publishing, 2013. ISBN: 978-184619-884-7 (paperback). 24.99 GBP. 310 pages. Mastering Scientific and Medical Writing: A Self-help Guide by…
The move towards patient engagement and patient involvement in healthcare decisions (“shared care”) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with…
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…
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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