EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...

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Ten recommendations to unlock the potential of big data for public health in the EU

20 January 2020 - The joint Big Data Task Force of EMA and the Heads of Medicines Agencies proposes ten ...

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Big data

27 November 2019 - Massive amounts of data are generated on a daily basis that could potentially be harnessed to ...

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Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars

24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...

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Big opportunities in big data, but EMA and industry just getting started

18 February 2019 - 250m genomes sequenced, but data trapped in silos. ...

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Role of big data for evaluation and supervision of medicines in the EU

15 February 2019 - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support ...

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EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?

14 September 2018 - The EU’s centralized procedure for the authorization of a new drug is performed by the EMA.  ...

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EMA’s proactive publication of clinical data a success

16 July 2018 - First report on unprecedented transparency policy shows high user satisfaction. ...

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Unparalleled access to clinical data - one year on

20 October 2017 - Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback. ...

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Data privacy in the age of big data

19 October 2017 - European Medicines Agency hosted meeting of EU Data Protection Officers. ...

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Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

26 July 2017 - Goldacre et al. set out to identify the policies of major pharmaceutical companies on transparency of trials, ...

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EMA and EUnetHTA step up interaction to align data requirements

4 July 2017 - A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access ...

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Use of big data to improve human and animal health

22 March 2017 - Task force to establish roadmap and recommendations for use of big data in assessment of medicines ...

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Call for experts in anonymisation of clinical data

23 March 2017 - EMA to set up technical group in the context of the publication of clinical data ...

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Clinical data for two more medicines now available online

1 February 2017 - First publication of clinical data corresponding to a withdrawn application. ...

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