Symposium E4
Big data, real world evidence and regulatory science

Wednesday 24 May 2017
Stockholmsmässan : A3


In recent years, progress in the collection, storage and analysis of real-world data has opened up promising
avenues for pharmaceutical innovation. The challenge for the pharmaceutical sciences will be to harness this
potential and utilize it to explore new treatment strategies and gather valuable evidence on the safety and
effects of medicines in clinical practice. This session will discuss the current state and ways forward.

Songlin Xue, Astellas, USA
Marieke De Bruin, University of Copenhagen, Denmark


09:00 – 09:10 Opening remarks
Songlin Xue, Astellas, USA

09:10 – 09:45 Big data as source for pharmaceutical innovation
Arnold Chan, National Taiwan University

09:45-10:20 Opportunities and challenges for Big Data to support regulatory decision making
Alison Cave, European Medicines Agency, UK

10:20 - 10:40 BREAK

10:40 – 11:15 Are there any pre-clinical Big Data?
Beatriz Lima, University of Lisbon, Portugal 

11:15 – 12:00 Panel discussion speakers, Q & A and closing remarks
Marieke De Bruin, University of Copenhagen, Denmark