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In the Bookstores - Volume 24, Issue

Statistical Thinking for Non-Statisticians in Drug Regulation (Second Edition) By John Wiley & Sons, 2014. ISBN: 978-1-118-47094-7 (hardcover).59.99 GBP. 368 pages. Writing for Science Journals: Tips, Tricks, and a Learning Plan By Geoff…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Medical Devices - Volume 29, Issue

The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…

Medical Devices - Volume 30, Issue

Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…

Localisation of promotional materials for pharma - Volume 33, Issue

Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…

News from the EMA - Volume 30, Issue

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…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

The clinical development plan - Volume 31, Issue

The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

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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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