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Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday - Volume 27, Issue

Pharma-Brexit is on its way. The announcement of the European Medicine Agency’s move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions…

Challenges of paediatric drug development and impact of paediatric legislation - Volume 21, Issue

Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

The perils of the unknown: Missing data in clinical studies - Volume 27, Issue

The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

Out on Our Own - Volume 26, Issue

Greetings, readers.For freelancers, receiving feedback is an important process for building a mutually productive relationship with a client. Positive feedback serves to encourage and helps develop core strengths, while constructive criticism is…

Out On Our Own - Volume 21, Issue

Another summer has come and gone. In this issue of OOOO, we are happy to feature Paul Woolley's novel approach of comparing employment and freelancing. I am sure many of us can identify with some of the points he raises. We thank Debbie Jordan for…

The new PubMed – underestimated regulatory obstacles - Volume 29, Issue

NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…

Systematic hospital collection of patient-reported outcome data via patient apps - Volume 27, Issue

Medical writers are increasingly likely to come across patient apps in their work, and we describe here the background and use of two apps for assessing patient-reported outcome (PRO). Systematic collection of PRO data via patient apps has been…

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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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