Managing IVDR Requirements & Country-Specific Submission Processes to Maintain European & RoW Market Access

• Navigating IVDR compliance across European countries to protect ongoing market access
• Addressing country-specific export restrictions in Brazil, China and France to keep global trials moving
• Balancing regulatory requirements with operational feasibility to avoid costly protocol amendments

Speakers:

Bethany Brunton

Associate Director, Biomarker & Diagnostic Operations

Johnson & Johnson