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Drug/Device and Device/Drug Combinations in the EU and USA (London, United Kingdom - April 19-20, 2018) - Research and MarketsThe "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. Why you should attend:
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) 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/th2x7w/rugdevice_and?w=4 View source version on businesswire.com: http://www.businesswire.com/news/home/20171214005661/en/ |