Medical Writing Public Disclosure Clinical data publication by the EMA: The challenges facing the pharmaceutical industry

Volume 27, Issue 2 - Public Disclosure

Clinical data publication by the EMA: The challenges facing the pharmaceutical industry

Abstract

As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised procedure to the EMA. Beforepublication of the documents in scope,companies have to ensure that personal dataof trial participants and personnel as well ascommercially confidential information isprotected. This article describes the challengesfor sponsors to implement and maintainefficient and up-to-date processes that alsotake into account the multitude oftransparency requirements of other channels,such as ClinicalTrials.gov.

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References

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Articles

Editorial
President’s Message
EMWA News
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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