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Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
Rather than equating disability with personal identity, we can better understand disability as the consequence of disabling environments. This alternative view suggests that changing the environment can enable people with sensory, motor, and…
Ecopharmacovigilance: A review of cause, impact, and remedies The Pharmacoviligance section in this issue opens the door to a very interesting topic: ecopharmacovigilance. This article is the result of a collaboration among volunteers of EMWA’s…
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…
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
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…
This article focuses on the medical device specific aspects of clinical investigations and does not aim to be a comprehensive introduction to clinical trials. We highlight the key differences to clinical studies of medicinal products in the…
First CAR-T cell medicine for mantle cell lymphoma October 16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…
Co-development, co-delivery, and evaluation of a Medical Writing module at master’s level Few universities offer courses in medical writing, and students from the biomedical sciences who wish to become medical writers typically need to learn…
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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