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.
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
- Background
- Life cycle management
- Exclusivity
- Patents
10.10 European regulatory guidance
- Life expectations of a competent authority
- Impact of the revision to the MDD
- EMEAs viewpoint management
12.30 Panel discussion on the EU regulatory requirements
13.45 Defining the regulatory approval route for your product
- Product classification
- Differences between device containing ancillary medicinal substances and medicinal products
14.30 Medical Device CE Certification - Notified Body expectations
- Devices containing ancillary medicinal substance
- Devices containing ancillary human blood derivative
- Post CE Marking expectations and changes
15.45 Highlights of major differences in documentation between:
- Device
- Drug and device
- Device and drug
16.15 Quality and non-clinical considerations for combination products
- Quality, pre-clinical and biocompatibility issues and how to address these for combination products
- What kind of non-conformance can we expect if you combine a drug and device?
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
- FDA's approach to combination products
- Requirements for product assignment, pre-market review and post-market regulation
- Good Manufacturing Practice (GMP) regulation
- Resources and guidance documents
- Hints and tips on good approaches
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
- What are tissue engineered and advanced therapy combination medicinal products?
- How are these new borderline products regulated in the EU and US?
- What are the practical challenges with development of these products?
- Impact of the proposed regulation on medical devices
15.30 Post market surveillance for combination products: Vigilance or pharmacovigilance?
For more information about this conference visit https://www.researchandmarkets.com/research/8q68ns/drugdevice_and?w=4
