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Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Regulatory Matters - Volume 32, Issue

Section Editors: Zuo Yen Lee, Clare Chang I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document Author: Tiago Silva Medical writing is not easy, especially for new writers still learning the ropes.…

Regulatory Matters - Volume 31, Issue

Two years into the pandemic outbreak, our lives have changed one way or another. The pandemic not only has impacted our lifestyle, it might also have impacted our career at some level. We might find ourselves needing to venture out onto new paths,…

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…

Regulatory Public Disclosure - Volume 31, Issue

A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…

Regulatory Matters - Volume 31, Issue

Contributors: Ri Xu (author) Zuo Yen Lee (section editor), Clare Chang (section editor) Hand and back muscle pain and how to avoid them: A regulatory writer's story Ri Xu Medical Writing. 2022;31(3)68-71. https://doi.org/10.56012/thzz1704

Regulatory Public Dislcosure - Volume 32, Issue

In this information-packed edition of Regulatory Public Discussion, Sam Hamilton provides detailed comparisons of regulatory templates and updates on processes for the Clinical Trials Information System. Contributor: Sam Hamilton (author and…

Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin - Volume 32, Issue

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…

Building resilience: Navigating challenges and thriving among the demands of regulatory writing - Volume 33, Issue

Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…

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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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