DxMA Web Cast Series 2010 - Session One
MARCH 18, 2010 | 1:00 PM - 2:00 PM
Session One: Regulatory Aspects of New Markers: FDA's Oversight of Companion Diagnostics
featuring Dr. Elizabeth Mansfield, Director of Personalized Medicine Staff, OIVD, Food & Drug Administration
Recent regulatory developments have signaled that the FDA intends to increase its regulatory oversight of certain pathways that have been used by IVD manufacturers to expedite the release of novel assays. These include analyte specific reagents (ASRs), laboratory developed tests (LDTs) and in vitro diagnostic multivariate index assays (IVDMIAs). Combined, these categories potentially encompass many companion diagnostics, genetic-based tests and other cutting-edge diagnostic products and technologies that have previously been unregulated or minimally regulated by the FDA.
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2010 Series: Increase Organizational Efficiency and Effectiveness for Launching New Markers
JUNE 10, 2010 | 1:00 PM - 2:00 PM
Session Two: Reimbursement for Innovative Diagnostic Technologies - How to be Strategic about Coverages, Coding & Payment
featuring Kuo Bianchini Tong, Founder & CEO, Quorum Consulting
Evaluate how CMS and private payers reimburse for devices, diagnostics and convergent technologies. Learn how published evidence drives coverage, coding and payment. Review the process and requirements to secure new codes, including a primer on the AMA CPT process. Understand how to align product pricing with reimbursement, and more importantly, how to secure reimbursement at a desired price point. Learn more about comparative effectiveness, cost effectiveness and how other macro level trends will affect your reimbursement strategy.
SEPTEMBER 9, 2010 | 1:00 PM - 2:00 PM
Session Three: Best Practice: Clinical Value Development - an Evidence-Based Case Study
NOVEMBER 11, 2010 | 1:00 PM - 2:00 PM
Session Four: Promotions Under GPP: Dos, Don'ts and Guidelines
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