The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

Regulatory Public Disclosure - Volume 34, Issue

This section provides important updates in the evolving world of the complex writing environment for regulatory medical writers.  Medical Writing. 2025;34(2):100–106. https://doi.org/10.56012/qbev3223

The soft skills gap for remote workers: Different perspectives - Volume 33, Issue

The COVID-19 pandemic has transformed the way we work, with many companies opting for fully remote or hybrid roles on a permanent basis. While remote working has many advantages, there are some soft skills that may deteriorate when working from home…

The Crofter: Sustainable Communications - Volume 32, Issue

Rising to the challenge of sustainability in healthcare communications Climate change is among the greatest global challenges facing humanity, and although progress on tackling the issue is slow, the pharmaceutical industry is taking it seriously.…

Regulatory Matters - Volume 33, Issue

Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…

In the Bookstores - Volume 27, Issue

In an ideal world, the deluge of information that comes our way from the tax office, insurance com pa nies, lawyers, computer software compa - nies, and suchlike would be written in plain English. Sadly, the reader is often left with the impression…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee  Briefing documents: Facilitating health authority interactions Author: Clare Chang  Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…