Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products is a course dedicated to practical guidance on borderline issues and combination products in the medical device, pharmaceutical and diagnostics industries.

Topics

• What your Competent Authority expects
• The European Regulatory Guidance
• How to define the approval route for your product
• Notified Bodies considerations on drug/device products
• Quality System Requirements for combination products
• The major differences in documentation and approval rates
• How to deal with Human Tissue engineering products
• FDAs regulatory approach to combination products
• Up-to-date on Post Market Surveillance for combination products

Who should Attend

Development and regulatory personnel in the medical device, pharmaceutical and diagnostics industries.