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Harmonising linguistic validation with AI: Precision, efficiency, and the human touch in patient-reported outcome translation - Volume 33, Issue

The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…

Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

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)…

An interview with Julia Cooper: Insights and experiences from leading a global medical writing team - Volume 33, Issue

Julia Cooper, PhD, is the Corporate Vice President and Head of Medical Writing Services at Parexel. In this interview, she shares her insights on the different aspects of leading a global medical writing team and on how she and her team at Parexel…

Global perspectives on EDIB: Advancing equity, diversity, inclusion, and Belonging in medical communications - Volume 33, Issue

The integration of Equity, Diversity, Inclusion, and Belonging (EDIB) principles within the field of medical communications is of paramount importance. EDIB principles, aligned with global guidelines on sustainability – encompassing labour…

Do you have what it takes to be a mentor or be mentored? - Volume 30, Issue

A skilled mentor can positively impact a mentee’s personal and professional development. A successful mentor-mentee relationship is contingent on mentor and mentee attributes, trust, and respect, and fit based on shared values and working style. To…

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…

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.…

Editorial - Volume 31, Issue

Medical devices are at the core of healthcare forming a large share of the global healthcare market. With consistent advances in technology, MedTech is enhancing our lives more so now than a few decades ago owing to accelerated digitisation and…

Seventh Freelance Business Survey: The freelance landscape 2018-2023 - Volume 32, Issue

The freelance medical writing landscape has evolved in recent years, with more market demand for competent medical writers who can work on a project basis. In January 2023, the European Medical Writers Association’s (EMWA) Freelance Business Group…

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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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