Current Edition

The Challenges of Implementing Non-interventional Studies in the EU

The European Medicines Agency (EMA) is piloting both adaptive pathways, to shorten time to market, and parallel scientific advice so that benefits and risk data requirements can be optimised for new medicines. Elements of both of these initiatives rely on real-world, post-authorisation data. Michael Cushion MSci DPhil, Consultant at Pope Woodhead & Associates Ltd, expounds the challenges of implementing non-interventional studies in the EU.