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Regulatory Matters - Volume 30, Issue

The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…

Introducing EMWA’s new AI Working Group - Volume 32, Issue

Artificial Intelligence (AI) is a broad umbrella term that refers to the use of computer algorithms to perform tasks that typically require human-like intelligence, such as reasoning, learning, decision-making, and perception. The new EMWA AI…

EMWA News - Volume 30, Issue

AMWA-EMWA-ISMPP Joint Position Statement on Medical Publications, Preprints, and Peer Review The AMWA-EMWA-ISMPP Position Statement on Medical Publications, Preprints, and Peer Review, published in Current Medical Research and Opinion (CMRO),…

Artificial intelligence – will we be replaced by robots? - Volume 28, Issue

Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…

Connecting the dots across the writing continuum - Volume 32, Issue

A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

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…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

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…

Message from the President - Volume 21, Issue

Dear Medical Writers Top of Form Bottom of Form The last time I wrote to you I briefly introduced myself and outlined some of the plans that I hope to realise during my year as president. However, as president I am only one of the members of the…

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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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