Molecular Diagnostics & the Changing Landscape: Considerations and Implications

June 05 – 06, 2013 — Sheraton Crystal City, Arlington, VA

Participate in interactive sessions ranging from current regulatory, reimbursement issues to latest government policies aimed at molecular diagnostics, healthcare reform and implications for diagnostics such as:

-Key issues in 510k and PMA molecular diagnostic submissions
-FDA’s current considerations for the regulation of molecular diagnostics
-Overview of FDA activities and initiatives related to personalized medicine
-Update on FDA’s recommendations for assessing analytical and clinical performance of biomarker-based in vitro diagnostic assays
-The role for the FDA in the future of drug and diagnostic development- Molecular Diagnostics and Personalized Medicine: Legislative Landscape and Policymaker Perspectives
- FDA Oversight & Regulation of Molecular Diagnostics and The OIR Perspective – Platform Technologies, Biomarkers, and Molecular Diagnostics Products
- United States Diagnostics Standards

Molecular diagnostics Leaders such as: Pamela Bradley, Staff Fellow, OIR/FDA; Alberto Gutierrez, Director, OIR/FDA; Donna Roscoe, Reviewer, OIR/FDA; Bob Lechleider, CMO, USDS, Inc.; Melina Cimler, VP, Quality and Regulatory Affairs, Illumina, Inc.; Mark Del Vecchio, Vice President, Regulatory Affairs, Nanosphere, Inc.; Danelle Miller, Global Regulatory Counsel, Roche Diagnostics; Lakshman Ramamurthy, Director, FDA Regulatory Strategy & Policy, Avalere Health LLC; Andrew Fish, Executive Director, AdvaMedDx; Duane Wright, Vice President, Government Affairs, AdvaMed address key regulatory considerations in developing molecular diagnostics and what it takes to make to create a good submission; developments impacting personalized medicine; co-development and the future of companion diagnostics; the changing landscape of molecular diagnostics reimbursement; and an afternoon on future proposals that could foster the introduction of new molecular diagnostics.

Please contact skinchen@advamed.org for Group Discounts
(discount does not apply to EGCC, Government, or Non-Profit Organizations)

TESTIMONIALS

" I learned as much from the questions/answers as from the presentations themselves. Enjoyed the interaction with other attendees and presenters!"

"It was very good that the content was focused on Diagnostics so most of the contents are relatable to what we do. Thank you very much for organizing!"

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