Co-Founder and Vice President
- 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