DUBLIN--(BUSINESS WIRE)--The "Drug/Device and Device/Drug Combinations in the EU and USA" conference has been added to Research and Markets' 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.
PRE-SEMINAR READING It is recommended that you have read the Medical Device Directives and the Essential Requirements Annex 1 & 3 prior to attending this seminar
Why you should attend:
- Understand the European Regulatory Guidance
- Know what your Competent Authority expects
- Gain an insight into Notified Bodies considerations on drug/device products
- Learn how to define the approval route for your product
- Clarify the major differences in documentation and approval routes
- Consider quality systems requirements for combination products
- Discover the FDAs Regulatory approach to combination products
- Hear how to deal with Human Tissue Engineered products
- Stay up-to-date on Post Market Surveillance for combinations products.
09.30 Chairman's welcome
09.40 Introductory overview
10.10 European regulatory guidance
12.30 Panel discussion on the EU regulatory requirements
13.45 Defining the regulatory approval route for your product
14.30 Medical Device CE Certification - Notified Body expectations
15.45 Highlights of major differences in documentation between:
16.15 Quality and non-clinical considerations for combination products
17.00 End of day one
09.00 Review of day one
09.05 Companion diagnostics
09.30 Clinical trial considerations
10.15 FDA's approach to combination products
11.20 FDA's approach to combination products - (continued) Mark Kramer
12.45 Panel discussion Compare and contrast EU and USA regulations
14.15 Human tissue engineered products
15.30 Post market surveillance for combination products: Vigilance or pharmacovigilance?
16.45 Close of forum
For more information about this conference visit https://www.researchandmarkets.com/research/wklw77/drugdevice_and