Description

Drug/Device and Device/Drug Combinations in the EU and USA is a conference dedicated to practical guidance on borderline issues and combination products in the medical device, pharmaceutical and diagnostics industries.

Drug/Device and Device/Drug Combinations in the EU and USA is a conference that covers topics such as:

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

Drug/Device and Device/Drug Combinations in the EU and USA brings together development and regulatory personnel in the medical device, pharmaceutical and diagnostics industries.

Drug/Device and Device/Drug Combinations in the EU and USA will be held on 18-19 May 2023.