Home  >  Program   WORKSHOP ON REGULATORY AFFAIRS FOR THE SUCCESS OF IVD-PRODUCT COMMERCIALIZATION Time Topics Speaker 9:00-9:40 am Introduction and welcome speech Chair Representatives from Taiwan Economic Develop / ITRI 9:40-10:10 am IVD Clinical studies - From 510k to PMA requirements Yu Ping Maguire 10:10-10:40 am Quality system and compliance - The similarities and differences in US and EU requirements Ed R. Kimmelman 10:40-11:00 am Break 11:00-11:30 am Taiwan IVD quality system Albert T.W. Li 11:30-12:00 am Panel All AM speakers and Taiwan speakers 12:00-1:00 pm Lunch 1:00-1:30 pm FDA submission preparation and approval Fred D. Lasky 1:30-2:00 pm Regulatory concerns of multiplex biomarkers, new genetic biomarkers and Drug / Diagnostic companion products. Pauline Y. Lau 2:00-2:30 pm How to approach the hurdle of IVD commercialization George C.S. Chou 2:30-2:50 pm Panel All PM speakers and Taiwan speakers 2:50-3:10 pm Break 3:10-5: 00 pm Round table discussion (See topics below) Wine and Cheese See speaker list below   Copyright © 2008 IVD  [ Website designed by fansio ]