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.
