DUBLIN--(BUSINESS WIRE)--The "Drug/Device and Device/Drug Combinations in the EU and USA" conference has been added to ResearchAndMarkets.com's offering.
The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing.
At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices.
This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.
Agenda
Day One
- 09.30 Chairman's welcome
- 09.40 Introductory overview
- 10.10 European regulatory guidance
- 11.00 Refreshments
- 11.20 European regulatory guidance - (continued)
- 12.30 Panel discussion on the EU regulatory requirements
- 12.45 Lunch
- 13.45 Defining the regulatory approval route for your product
- 14.30 Medical Device CE Certification - Notified Body expectations
- 15.15 Discussion
- 15.30 Refreshments
- 15.45 Highlights of major differences in documentation between
- 16.15 Quality and non-clinical considerations for combination products
- 16.45 Discussion
- 17.00 End of day one
Day Two
- 09.00 Review of day one
- 09.05 Companion diagnostics
- 09.30 Clinical trial considerations
- 10.15 FDA's approach to combination products
- 11.00 Discussion
- 11.10 Refreshments
- 11.20 FDA's approach to combination products - (continued)
- 12.45 Panel discussion Compare and contrast EU and USA regulations
- 13.15 Lunch
- 14.15 Human tissue engineered products
- 15.00 Discussion
- 15.10 Refreshments
- 15.30 Post market surveillance for combination products: Vigilance or pharmacovigilance?
- 16.15 Discussion
- 16.45 Close of forum
For more information about this conference visit https://www.researchandmarkets.com/research/m7sgh4/2day_seminar?w=4
