COVID-19 success will require overcoming a variety of obstacles, from assay design and regulatory hurdles to sample sourcing and reimbursement considerations.
This week's FierceBiotech is brought to you by Precision for Medicine.
Date: Thursday, June 11, 2020Time: 1pm ET / 10am PTDuration: 1 Hour
Many COVID-19 diagnostics programs have been delayed or derailed because of unanticipated challenges. COVID-19 success will require overcoming a variety of obstacles, from assay design and regulatory hurdles to sample sourcing and reimbursement considerations. This webinar will explore real-world examples that will help you anticipate pitfalls, mitigate risk and accelerate development.
Register to learn the valuable insights Precision has gained from participation in multiple COVID-19 research studies to understand the contingencies for success and, just as critical, to anticipate pitfalls that can be avoided.
Understand how to:
Build a biospecimen foundation for diagnostic development
Navigate the regulatory landscape for serology tests, from EUA to 510(k)
Leverage important design considerations for market access
Recommended for:
Biotech R&D teams developing COVID-19 antibody tests Clinical operations specialists managing studies for 510(k) submission
Regulatory affairs teams working on EUAs or formal submissions to the FDA
Procurement specialists looking to identify appropriate specimens for their research
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