Harmonizing clinical trial assessment and supervision in the EU through the portal and database established by the new EU Clinical Trial Regulation, and maintained by the EMA, is not the only change rippling through clinical trials in Europe, explain Dr. Mireille Muller, Regulatory Policy Director for Novartis A-G in Switzerland; and Dr. Greet Musch, Director-General for Pre-Authorisation at the Federal Agency for Medicines and Healthcare Products of Belgium. Dr. Muller and Dr. Musch will help lead discussions on this topic at DIA Europe 2018.