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How Big Data Can Be Used for the Development and Regulation of Medicines

EMA workshop broadcast live on 14-15 November 2016
08 Nov 2016
Translational research

The European Medicines Agency (EMA) is organising a workshop on 14-15 November 2016 to identify opportunities for big data in medicines development and regulation, and to address the challenges of their exploitation. A live broadcast of the workshop can be followed by clicking on the 'multimedia' tab on the event page.

Big data is a term which describes the collection of extremely large sets of information which require specialised computational tools to enable their analysis and exploitation. These vast volumes of data have the capability to significantly contribute to the way the benefit-risk of medicines is assessed over the entire lifecycle. A subset of big data is real world evidence, which encompasses the use of sources such as electronic health records, registries, hospital records and health insurance data. Already used to support pharmacovigilance activities, real world evidence has the potential to support product development and the assessment of performance of a medicine on the market.

While creating huge opportunities, there are also significant challenges in the exploitation of these data. For example there is a need to establish appropriate access to the data, to understand the strengths and limitations of the data and to apply new analytical methods to integrate and analyse heterogeneous datasets in order to generate conclusions which contribute to regulatory decision making. Importantly, compliance with data protection legislation ensuring robust mechanisms to protect patient confidentiality is critical for securing patient trust.

The workshop will bring together a wide range of individuals from the healthcare environment and technology companies, who can inform on the advances being made in the field of big data and the opportunities for its application in medicine regulation. This landscaping exercise will help regulators to determine the best approaches to using big data for the development, authorisation and post-marketing surveillance of medicines.

More details on this workshop's sessions and speakers are provided in the agenda for the meeting.

Individuals interested in tweeting on this event are invited to use the hashtag #bigdata4medicines.


Last update: 08 Nov 2016

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