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In the Bookstores - Volume 23, Issue

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…

Interview with Professor Matthias Rose on developing patient-reported outcomes and the PROMIS initiative - Volume 27, Issue

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…

Regulatory Matters - Volume 30, Issue

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…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

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…

Writing for patients: When and how? - Volume 29, Issue

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…

The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday - Volume 27, Issue

Pharma-Brexit is on its way. The announcement of the European Medicine Agency’s move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions…

The Crofter: Sustainable Communications - Volume 30, Issue

Greetings from the croft! I think it’s a neat coincidence that I have the pleasure to write my first editorial to this edition of The Crofter in the Medical Writing special issue on mentorship. I don’t have an official mentor but ever since I…

Out on Our Own - Volume 30, Issue

Editorial Welcome readers, I’ve lost count how many times people ask me, what is a medical writer? And it isn’t just my mum and aunt who ask me such a question; medical doctors, PhD students, and academic professors are often surprised that…

Innovative use of master protocols for pivotal studies in rare diseases - Volume 34, Issue

Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

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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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