29 - 31 October, 2018 | Mercure Hotel Amsterdam City, Amsterdam , Netherlands

Steve Dew


Associate Director Combination Products and Medical Devices
Biogen


10:20 AM Exploring the Similarities and Differences between the US and European Markets

  • EU vs. US regulatory landscape: Exploring and defining the key differences, similarities and subsequent impacts on each region
  • Understand the regulatory pathways and how to successfully navigate between drugs and devices
  • Learn how the new EU medical device regulation impacts combination products regulated as drugs

11:25 AM PANEL DISCUSSION: Navigating the Complex Regulatory Landscape from Both Drug and Device Approaches

  • Understanding how combination products are defined and classified globally: EU, US and Asia
  • Making sense of the regulatory contradictions and focusing on the specific requirements within the EU?
  • Gaining a deeper understanding of the roles of Competent Authorities and Notified Bodies
  • Post Brexit impacts on drug device combination product regulations


Check out the incredible speaker line-up to see who will be joining Steve.

Download The Latest Agenda