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

Viky Verna


Co-Founder and Vice President
confinis


9:10 AM Global Trends and the US FDA Regulatory Landscape

  • Global snapshot of the regulatory landscape: Challenges and future trends
  • A comprehensive overview of the US FDA regulation for combination products: How has it evolved and will it change in the future?
  • Reviewing the drug and-device regulation within the US market and how it applies to combination products
  • Recommendations for drug-device manufacturers developing, launching and marketing combination products


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 Viky.

Download The Latest Agenda