High quality data to empower data-driven medicines regulation in the European Union

10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...

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Big data use for public health: publication of Big Data Steering Group workplan 2022-25

28 July 2022 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...

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EMA launches pilot project on analysis of raw data from clinical trials

12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...

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Generating high quality evidence from registry based studies

26 October 2021 - EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on ...

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Working towards harmonised access to clinical trial data across European drug regulatory agencies

31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...

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European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps

13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...

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International regulators and WHO call for wider public access to clinical data

7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...

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Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say

10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...

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Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21

14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...

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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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