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Cosmetic regulatory writing - Volume 23, Issue

On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…

Writing lay summaries: What medical writers need to know - Volume 27, Issue

Lay summaries are critical for building publictrust in clinical research and therefore forrecruiting patients. They are also an importantpart of efforts to improve data transparency.Due to new global regulations, lay summarieswill soon probably…

Biostatistics and medical writing: Synergy in preparing clinical trials documents - Volume 25, Issue

Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…

Good Writing Practice - Volume 26, Issue

Syntactic Structure - Inter-sentenceIncrementalism: SentencesInter-sentence incrementalism is an expansion of information, often secondary, into a sentence rather than a reduction of the information to a clause or phrase and incorporation (sentence…

Good Writing Practice - Volume 29, Issue

The misagreement in number (singular vs. plural) between subject and verb is caused by subject number ambiguity, either intrinsic (the subject itself) or extrinsic (the effect of subject modification).

Good Writing Practice - Volume 26, Issue

Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…

From editors abroad into businesswomen back in Brazil - Volume 22, Issue

After living for 12 years in the United States, and a career shift from bench scientist in molecular biology to science writer and editor, the author goes back home to Rio de Janeiro, Brazil, to found Publicase, a science communication company…

The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…

Transparency and the healthcare industry: The Sun is shining - Volume 22, Issue

The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…

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…

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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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