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Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD - Volume 32, Issue

Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…

President’s Message - Volume 33, Issue

Welcome to the latest issue of Medical Writing. Following our record-breaking Spring conference in Valencia, Spain, which saw an unprecedented number of attendees, I am both humbled and excited to address you as the new President of EMWA. The…

AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing - Volume 28, Issue

The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) recognise the challenges to scientific publishing being posed by predatory…

Changes to working practices in medical communications during the COVID-19 pandemic: Insights from two surveys - Volume 31, Issue

Successive waves of COVID-19 have altered opinions and working practices. We conducted a survey in early 2020 among 759 members of the medical communications community, recruited via our network, seeking their experiences, opinions, and insights.…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…

In the Bookstores - Volume 31, Issue

As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…

Differences between writing for medical devices and pharmaceuticals: An update - Volume 31, Issue

Although the medical device and pharmaceutical industries are related, they are governed by distinct regulatory systems. Despite the similarities, the inherent differences between medical devices and drugs have implications for clinical research…

Regulatory Matters - Volume 30, Issue

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

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…

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),…

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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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