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browse by categories     Audio Conference Archive     Audio Conferences     Past Conference Documentation     Webinar Archive     Webinars     Workshops     - December     - February     - January     - October product EU Diagnostic Regulatory Workshop: Diag Comp Registrati This product was added to our catalog on Thursday 08 October, 2009. Item #: Price:  $1,050.00    Product description European Diagnostic Regulatory Affairs Workshop: Diagnostic Company Registration December 7th, 2009 Pathways For Ensuring Positive Regulatory Decisions in Europe, Obtaining CE Marks And Maintaining Compliance In An Evolving Marketplace. Topics to be Covered Understanding Current EU Regulatory Requirements Impacting Diagnostic Approvals Recognizing Differences in EU vs. Non-EU Country Regulations for Diagnostic Tests Recognizing the Impact of Evolutions of the MDD on Diagnostic Product Integration Strategies in Notified Body Selection Notified Body’s Perspective on CE Marks Impact of Clinical Trials on Obtaining CE Marks in Europe Understanding Data Requirements for Diagnostics to Obtain a CE Mark Case Study: US-Based Manufacturers Obtaining CE Mark for New Diagnostic Tests Opportunities in Self-Declaration for New Diagnostics Fees Fees include course materials, breakfast, lunch, & refreshments Info For information regarding registration please contact: Paul Hernandez at phernandez@q1productions.com or call 312.602.9684 This registration is strictly for diagnostic executives. To register as a solution provider/consultant visit:http://bit.ly/1FocDC. All on-line registrations are subject to review by Q1 Productions All on-line registrations are subject to review by Q1 Productions

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