Drug/Device and Device/Drug Combinations in the EU and USA Seminar: London, United Kingdom - September 12-13, 2019
DUBLIN, May 23, 2019 /PRNewswire/ -- 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.
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.
Who Should Attend:
Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating pharmaceutical' ingredients, or pharmaceutical products incorporating a device or delivery system.
Agenda:
Day one
09.30 Chairman's welcome
Dr David Jefferys
09.40 Introductory overview
- Background
- Life cycle management
- Exclusivity
- Patents
Dr David Jefferys
10.10 European regulatory guidance
- Life expectations of a competent authority
- Impact of the revision to the MDD
- EMEAs viewpoint management
Dr Elizabeth Baker
11.00 Refreshments
11.20 European regulatory guidance - (continued)
Dr Elizabeth Baker
12.30 Panel discussion on the EU regulatory requirements
12.45 Lunch
13.45 Defining the regulatory approval route for your product
- Product classification
- Differences between device containing ancillary medicinal substances and medicinal products
Dr Tina Amini
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
Dr Tina Amini
15.15 Discussion
15.30 Refreshments
15.45 Highlights of major differences in documentation between:
- Device
- Drug and device
- Device and drug
Dr Tina Amini
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?
Dr Tina Amini
16.45 Discussion
17.00 End of day one
Day two
09.00 Review of day one
Dr David Jefferys
09.05 Companion diagnostics
Dr David Jefferys
09.30 Clinical trial considerations
Dr David Jefferys
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
Mark Kramer
11.00 Discussion
11.10 Refreshments
11.20 FDA's approach to combination products - (continued) Mark Kramer
12.45 Panel discussion Compare and contrast EU and USA regulations
13.15 Lunch
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
Alison Wilson
15.00 Discussion
15.10 Refreshments
15.30 Post market surveillance for combination products: Vigilance or pharmacovigilance?
Dr David Jefferys
16.15 Discussion
16.45 Close of forum
For more information about this conference visit https://www.researchandmarkets.com/r/zibgy
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