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Journal Watch - Volume 29, Issue

Journal Watch is based on the French language blog, Rédaction Médicale et Scientifique, by Hervé Maisonneuve, available at www.redactionmedicale.fr.

Journal Watch - Volume 28, Issue

Journal Watch is based on the French language blog, Rédaction Médicale et Scientifique, by Hervé Maisonneuve, available at www.redactionmedicale.fr.

In vitro plants: How to open a jar containing bioactive phytochemicals - Volume 32, Issue

Due to the increasing demand for phytochemicals, plant in vitro cultures are a noteworthy, environmentally sustainable method, enabling the biotechnological production of bioactive compounds. Medical writers can find writing scientific articles in…

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

The new value of clinical data in Europe - Volume 29, Issue

The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…

Leading a team virtually: A manager’s perspective - Volume 31, Issue

Remote working is the new normal since the COVID-19 pandemic, so learning to lead a virtual team successfully is now an essential core competency for organisational leaders. The transition from co-located teams to virtual teams has benefitted…

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…

Getting Your Foot in the Door - Volume 26, Issue

In this June edition of GYFD, we are presenting the first part of a series on visa regulations and work permits related to internships in the EU. I would like to thank Van-Anh Dao for doing the legwork of researching the German requirements. We will…

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Scope

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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