The focus of this meeting was on the implementation of the new General Data Protection Regulation (Regulation (EU) No 2016/679) , which will apply as of 25 May 2018. The new Regulation represents a complete overhaul of EU data protection rules, giving citizens back control of their personal data. “With this new Regulation, European citizens will have a high, uniform level of data protection in all 28 countries of the EU fit for the digital era,” explained Wojciech Wiewiórowski, the European Data Protection Assistant Supervisor. “The updated rules will help us tackle new threats presented by big data.” Granting citizens control and access to their personal data is an increasing challenge for organisations in the digital era. The internet has opened the gate to nearly limitless sources of data and this highlights the importance of protecting citizens’ privacy and their sensitive data, in all sectors of business and society. As the hosting organisation, EMA presented as an example the opportunities and challenges presented by big data in biomedical research across the EU. The analysis of large datasets or ‘big data’, has become a major driver of innovation and success in medicines research and development. However, the power of big data analytics to bring to light previously unseen relationships between data also raises ethical problems, which may threaten the huge opportunities it offers. Presenting an overview of EMA’s recent work on big data, Alison Cave, Principal Scientific Administrator at EMA said: ”EMA is committed to encouraging ethically responsible, innovative uses of biomedical big data and to protect personal data of patients and users of medicines. We are working to transform these challenges into values, exploring new ways of gathering and validating data and the evidence derived from it for the benefit of patients.” Data protection will remain high on the agenda, especially as the EU prepares for the coming into operation of the new EU rules on data protection. Data protection officers from the institutions, bodies and agencies will continue to work with the European Data Protection Supervisor to make sure their organisation is ready for 25 May 2018. More Information On EMA