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Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

Statistical analyses and methods in the published literature: The SAMPL guidelines - Volume 25, Issue

Despite calls for guidelines on reporting statistical aspects of studies, most journals have still not included in their instructions for authors more than a paragraph or two about reporting statistical methods and results. However, given that many…

AuthorAID: An international service and chance to serve - Volume 22, Issue

Medical and other researchers in developing countries conduct much valuable research. Yet difficulties in writing and publication often prevent this research from being widely known. AuthorAID (http://www.authoraid.info), a project of the…

News from the EMA - Volume 24, Issue

The articles included in this section are a selection from the EMA's news and press release archive for December – February 2015. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.

News from the EMA - Volume 31, Issue

The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu. Anuradha Alahari (editor)

News from the EMA - Volume 24, Issue

The articles included in this section are a selection from the EMA's news and press release archive for August–November 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu

News from the EMA - Volume 23, Issue

The articles included in this section are a selection from the EMA's news and press release archive for March–June 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.

News from the EMA - Volume 25, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive for August 2016 – Oct 2016. More information can be found on the Agency’s website: www.ema.europa.eu of medicines to treat…

News from the EMA - Volume 24, Issue

The articles included in this section are a selection from the EMA's news and press release archive for June–August 2015. More information on the work of the EMA can be found on its website: www.ema.europa.eu

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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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