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Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

Regulatory Writing - Volume 21, Issue

The European Medicines Agency looks to the future At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According…

Regulatory Matters - Volume 26, Issue

Brexit and the European Medicines Agency The British government has formally triggered Article 50, setting in motion Brexit and negotiations can begin in earnest. If before, politicians could gloss over the complexities, they are now obliged to…

Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results - Volume 24, Issue

The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…

Profile: An interview with Art Gertel on the Budapest Working Group - Volume 24, Issue

Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…

"Processing health-related data for scientific research: Is consent an appropriate legitimate ground?" - Volume 29, Issue

I first met Brussels-based lawyer, An Vijverman, at the European Centre for Clinical Research Training Data Transparency Conference in February 2019. The conference brought together the clinical trials industry – sponsors and contract research…

Grant writing and editing - Volume 28, Issue

Grant writing and editing is a medical writing subspecialty of growing importance. This article describes the roles available for medical writers who specialise in grant proposals. It also offers seven grant-writing tips. Finally, the article…

The Webscout - Volume 22, Issue

Public health funding constitutes a big part of European social systems' expenditures. Governments and health insurance companies are thus interested in reducing spending. Applying pricing initiatives to innovative products confronts pharmaceutical…

News from the EMA - Volume 26, Issue

The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from July 2017 to September 2017. More information can be found on the Agency’s website: www.ema.europa.eu

News from the EMA - Volume 26, Issue

November 15, 2016 — The EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The…

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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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