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.
As part of the life sciences community, Precision wants you to succeed in the fight against COVID-19. Use the valuable insights we’ve 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 and 510(k) submission
- Navigate the regulatory landscape for serology tests, from EUA to 510(k)
- Leverage important design considerations for market access
- 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