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EU seminar to focus on big data use for medicines development, regulation

Xinhua, November 9, 2016 Adjust font size:

The European Medicines Agency (EMA) announced on Tuesday that it is organizing a workshop to determine opportunities for big data in medicines development and regulation.

Set for Nov. 14 to 15, the event will gather a wide range of individuals from the healthcare circle and technology firms that will introduce the progress being achieved in the field of big data and the opportunities for its application in medicine regulation.

The workshop will help regulators to identify the best approaches to using big data for the development, authorisation and post-marketing surveillance of medicines.

Big data, the collection of extremely large sets of information, are capable of remarkably contributing to the way the benefit-risk of medicines is assessed over the entire lifecycle. A subset of big data is real-world evidence which possesses the potential to support the development and the assessment of performance of a medicine.

Meanwhile, there are also great challenges in the exploitation of big data, such as the need to establish appropriate access to the data and the need to comply with data protection legislation. Endit