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Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

The changing face of (benefit-)risk management - Volume 24, Issue

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…

Measuring quality of life – theoretical background - Volume 27, Issue

Patient-centred medicine has come out of the increasing importance of patients’ voices in disease management. As part of this, health related quality of life (HR-QoL) has become an important part of assessing treatment outcome and the quality of…

Veterinary Medical Writing - Volume 32, Issue

Abstract Human medicine has recently seen a move away from the paternalistic patient-physician paradigm course to a collaborative one, where “shared decision-making” is a core principle. No longer a passive bystander, where their case management is…

Veterinary sustainability - Volume 31, Issue

Respected for their knowledge of animal health and disease, veterinarians safeguard animal health and welfare and, where applicable, the productivity of animals under their care. With the threats posed by climate change, the veterinary profession…

The evolving landscape of medical education in oncology - Volume 21, Issue

The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…

The Webscout - Volume 21, Issue

Diabetes and Psychology You all may know that diabetes is a metabolic disease leading to secondary micro- and macrovascular complications, like nephropathy, neuropathy, and cardiovascular diseases. You may also know that these microvascular…

Strategic medical writing in the post-authorisation phase - Volume 23, Issue

This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…

EU sourcing requirements for animal-derived materials - Volume 31, Issue

Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…

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…

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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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