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Volume 23, Issue 1 - Software for Medical Writers

News from the EMA

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data

 

From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing more than 1000 comments received during the public consultation on its draft policy on publication and access to clinical-trial data, which ran from June to end of September 2013.

The public consultation on the policy has generated input from an unprecedented range of stakeholders. Patients, healthcare professionals, pharmaceutical industry representatives, researchers, transparency campaigners, academic and public institutions, health technology assessment bodies, and a range of others sent their comments to the Agency. Many of the contributors provided detailed in-depth comments, some of them substantial, some of them technical, including suggestions relating to methodological and technical aspects of the implementation of the policy.

The Agency is grateful for this exceptional contribution from its stakeholders. As part of its collaborative approach to developing a methodology for the release of clinical-trial data with its stakeholders, the Agency is currently devoting attention to all comments received and reaffirms its commitment to transparency and the principles of publication and access to clinical-trial data.

In order to conduct the appropriate in-depth analysis required, the Agency will spend additional time in this reviewing phase which may therefore delay the finalisation of the policy initially planned for the end of 2013. An update on timelines will be provided at the latest following the EMA Management Board meeting on 11–12 December 2013.

The Agency has embarked on the development of a policy on publication and access to clinical-trial data, because it believes that the release of data is about establishing trust and confidence in the system. The Agency is also firmly of the opinion that the availability of data broadens the scientific knowledge base, fosters innovation, and encourages investment in the development of medicines and ultimately benefits public health.

More information on the work of the European Medicines Agency can be found on its website: http://www.ema.europa.eu.

 

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In this issue of Medical Writing
Message from the President
EMWA social media team
News from the EMA
Taming Microsoft Word®
The secrets of Microsoft Word®. Part I – ‘Find and Replace’ and en-dashes
Organising the review process in Microsoft Word®
Document templates for medical writers
Getting more out of PowerPoint®
Consolidated data analysis and presentation using an open-source add-in for the Microsoft Excel® spreadsheet software
Datavision™ – What do medical writers need to know?
Software for translators
Graphing software for medical writers
A medical writer's must-have software
Zotero: A free and open-source reference manager
Origin and development of English for Medical Purposes. Part I: Research on written medical discourse
Profile: An interview with Karina Ruth Tabacinic on some fundamental concerns of medical translation
A first-timer's perspective on the 2013 EMWA conference in Barcelona
English Grammar and Style
Regulatory Writing
The Webscout
Medical Communications
In the Bookstores
Manuscript Writing
Out On Our Own

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  • Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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