Pamela Ebrahimi

Pamela Ebrahimi

Company: CDRH, U.S. Food and Drug Administration

Job title: Deputy Branch Chief, Molecular Genetics Branch

Seminars:

Approval of Companion Diagnostics by the U.S. FDA: Exploring the Current Regulatory Environment & Important Hurdles to Overcome 8:35 am

• Updates on biomarker-driven trial enrolment policy for regulatory compliant companion diagnostic development • Exploring current approaches and challenges for companion diagnostic approval in the US • How U.S. FDA members work together to help CDx development planning • Outlook on the changing companion diagnostics environment and resulting questions and challenges emerging in-line with new…Read more

day: Day 1 morning

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