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Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

Innovative use of master protocols for pivotal studies in rare diseases - Volume 34, Issue

Recent years have seen the development of clinical study protocols that introduce more complex design features into the usual gold-standard randomised controlled trials (RCTs). Complex protocols are potentially useful for drug evaluation in the…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

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…

Publisher perspectives on plain language summaries of scientific publications: An Open Pharma survey - Volume 33, Issue

Plain language summaries (PLS) of scientific publications can help to make scientific literature more understandable. In healthcare, PLS can contribute to informed decision- making by healthcare professionals, patients, and their caregivers. In late …

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editors: Louisa Ludwig-Begall, Sarah Kabani Saving the planet, one EMWA conference at a time Author: Adam Jacobs I had been a frequent business traveller for some years until not so long ago. Most of my trips were by plane. I would…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editor: Kimi Uegaki Breaking barriers in sustainable development in East Africa: How Lightup Impact is leveraging communications to shift the power to the right actors Authors: Nicole Bezuidenhout, Valeria Santoro, Jeniffer Muganda …

English Grammar and Style - Volume 24, Issue

In this issue • We continue Michael Schneir's fascinating series on distractions in medical and scientific writing, this time concentrating on non-pronoun-induced backtracking with adverbs, verbs, and nouns. This sounds a little…

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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