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How can real-world data, registries, and databases address the challenges of rare diseases? - Volume 34, Issue

A goal for all diseases is a treatment that works to prevent, halt, or reverse their effects – essentially, a cure. Achieving this requires early diagnosis, knowledge of disease mechanisms, and effective treatment. For rare diseases, each of these…

The Webscout - Volume 26, Issue

Observational studies are better than their reputation. They have their place in the continuum of clinical research. The following recommended reading will give you an overview of the types of observational studies and their role.

English Grammar and Style Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 2 – Single syntactic unit revision - Volume 24, Issue

This is the second of a series of three articles on pronouns that cause distraction by making the reader backtrack. In this article, we examine a technique for eliminating backtracking by making a single change to the construction of the sentence.…

English Grammar and Style: Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 3 - Double syntactic unit revision and syntactic position revision - Volume 24, Issue

This is the last of this series of three articles on pronouns that cause distraction by making the reader backtrack. In the first part of this article, we examine a technique for eliminating backtracking by making two changes to the construction of…

Good Writing Practice - Volume 29, Issue

An adjective clause displaced from its modifee by an intervening syntactic unit is a distraction. Another distraction is the vague adjective clause that seems to refer to an entire sentence rather than to a definite modifee. Such vagueness…

Good Writing Practice - Volume 30, Issue

Grammatical misagreement in function: Modifier to modifee Knowledge of the grammatical function of a modifying syntactic unit facilitates understanding a misfunctional distraction and, in turn, its revision option.

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…

Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards - Volume 26, Issue

Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…

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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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