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

Johannes Keuschnigg


Senior Manager, Regulatory & Medical Device
Sandoz


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

4:15 PM A Biosimilars Perspective on Combination Product Development and Registration

  • What points do biosimilar companies have to consider while following the design control process
  • Developing a regulatory strategy leading to fast approvals
  • Experience from recent EMA and FDA reviews of combination products


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

Download The Latest Agenda