focusevaluation

2018 AMDM Focus Meeting Evaluation

FDA Update
Brendan O'Leary *

Industry Update – Allyson Mullen *

Software Pre-Certification - Deb Rasmussen *

Third Party Review - Elizabeth Hillebrenner *

Third Party Review - FDA Panel - Reena Philip... *

Significant Risk Determination - Yun-Fu Hu *

New Approval, EGFR Mutation Test - Helen Wu *

China IVD Registrations - Grace Fu Palma *

Supporting Global Market Access - Sarah Parsons *

Update on IVDR - Stefan Burde *

Prenatal Testing - Michelle Roeding *

HPV - Sam Rua *

POC Testing - Erika Ammirati *

Use of Public Human Genetic Variant - Laura Koontz *

Considerations for Design, Development... - Zivana Tezak *

Case Study, Breakthrough Devices - Doug Jeffery *

Myriad BRCA Single-site Approval - Jolette Franco *

Liquid Biopsy - Jennifer Dickey *

NGS Regulatory & Reimbursement Update
Lynne McBride *

Please rate the overall event on format & organization *

Please rate the overall event on facilities / food *

Please rate the overall event on overall relevance / value *

Please tell us your years of regulatory experience *

What suggestions for improvements or additions to the program would you offer? *

What speakers/topics would you like to suggest for future programs? *

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