Two Day Seminar: Drug/Device and Device/Drug Combinations in the EU and USA (London, United Kingdom - November 9-10, 2017)

DUBLIN, October 10, 2017 /PRNewswire/ --

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.

Agenda:

Day one

09.30 Chairman's welcome

09.40 Introductory overview

10.10 European regulatory guidance

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) Mark Kramer

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/dmsr36/drugdevice_and

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Laura Wood, Senior Manager
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