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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from February 2022.
As COVID-19 swept across the world, governments and companies raced to develop tools to slow the spread of SARS-CoV-2.
COVID-19 tests are a critical component of the fight against the pandemic and test developers answered the call to provide tests to meet the demand. Several high-profile instances of false negatives and false positives, combined with the potential for these false results to impact businesses and schools that have included testing as part of their back-to-work/school strategies, opening the doorway to potential product liability litigation for the test developers.
This presentation will discuss the scientific and regulatory issues of COVID-19 tests. First, we will present the scientific basics of SARS-CoV-2 and what biomarkers are used to detect COVID-19. This section will include an overview of the types of COVID-19 tests and a discussion of the factors that impact accuracy, detailing both those that the developers can control and those they cannot. Second, it will cover the regulatory landscape, providing an overview of the FDA Emergency Use Authorization Guideline and how the guidance has changed over time. This part of the presentation will include a comparison between the 510(k) and various EUA pathways, how the definition of ‘State of the Art’ has changed with reference to the scientific background established previously. Lastly, the program will take a look at the various types of issues the FDA has worked through over the course of the pandemic to date.
Upon completion of this program, attendees will be able to:
Dr. Christie Bergerson received her Ph.D. in orthopedic biomechanics and went on to develop in vitro diagnostic analyzers at Abbott Labs, including the hardware, software and firmware components. Now she is a consultant and splits time between her main role at Exponent, her position as an adjunct professor at Johns Hopkins and her role as a contributing member on the ISO artificial intelligence standard subcommittee. In her free time, you can find Dr. Bergerson horseback riding through the parks surrounding Philadelphia. You can learn more about Dr. Bergerson via her Exponent and LinkedIn profiles, or email here at firstname.lastname@example.org.
Alexis Sauer-Budge specializes in the intersection between biology and materials. Trained in chemistry and biophysics, she applies her interdisciplinary experience to the development and design analysis of products for the medical device, biotechnology, and pharmaceutical industries. She has particular expertise in clinical diagnostics (the testing and identification of biological materials), including nucleic acids (DNA and RNA), proteins, microbes (bacteria, fungi, antimicrobial resistance), and human specimens (blood, urine, saliva, etc.). Throughout her career, Dr. Sauer-Budge has been involved in the research and development of biosensors, sample preparation techniques, microfluidic devices, anti-fouling coatings, wearable devices for the continuous monitoring of biomarkers, implants, 3D bioprinting, bench-top instrumentation, and multi-functional surgical tools. She is an active participant in peer review, including serving as a standing member of an NIH review committee and has published more than 35 articles.
RAPS will send an electronic letter or a certificate of attendance following the workshop.
For additional hands-on support, you can connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help