Workshop Format 3.0

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Summary

Join AAPS for a multi-day, eight-part webinar series in which we explore testing and analytical approaches; how regulatory agencies and companies are making a rapid response possible; re-purposing drugs we already have; and maintaining both business continuity and the global supply chain in a pandemic.

This event is complimentary for AAPS members in good standing. If you are not an AAPS member, but would like to participate in this vital conversation, please join or renew before start of the session(s) you’d like to attend. 

June 30, 2020
11:00 am – 12:30 pm

Session 1: Independent Performance Evaluation of COVID Tests - PCR-based assays

qPCR is considered the gold standard of viral genomic testing. It is also a critical tool for early detection of the virus in patients. What has the experience been with qPCR in terms of assay challenges, false +/- results and overall comparability? Speakers from several independent initiatives comparing test results will discuss their findings.

1:30 pm – 3:00 pm

Session 2: Independent Performance Evaluation of COVID Tests - Serology tests

Serology testing is relied upon most heavily in the assessment of patients across the COVID-19 pandemic. They are used in laboratory and point-of-care settings, often used to make critical patient care decisions. A large variety of assays has been developed in parallel and approved for use by regulators world-wide. Still, comparability and assay performance challenges remain. This session will examine data from indipendent assay comparison studies and discuss paths forward to future improvements.

July 1, 2020
11:00 am – 12:30 pm

Session 3: Regulatory Perspectives

Bioanalytical tests from a regulatory point of view can be in different realms, i.e. the diagnostic vs. the drug/device space for the US. This can affect how assay performance is defined and reviewed. This session will examine policy considerations from both viewpoints, but also provide international perspective and experiences.

1:30 pm – 3:00 pm

Session 4: New Assay Approaches, Reagents, and Future Improvement

As we learn more about the performance of the existing assays, it is important to discuss future expectations and which developments are necessary to further improve measurement quality, either through different assay approaches or tools like standards. This session will discuss next generation assay approaches, as well as metrology and standardization work intended to improve measurement performance and data quality.

Featured Speakers

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Featured Speaker 1

Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,200 across 10 global sites. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Dr. Piervincenzi brings more than 25 years of industry experience across the pharmaceutical sciences, research and business strategy.

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Featured Speaker 2

Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,200 across 10 global sites. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Dr. Piervincenzi brings more than 25 years of industry experience across the pharmaceutical sciences, research and business strategy.

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Featured Speaker 3

Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,200 across 10 global sites. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Dr. Piervincenzi brings more than 25 years of industry experience across the pharmaceutical sciences, research and business strategy.

Registration Information

AAPS Members in good standing may access this webinar series live or the post-event recordings for free.

Current Members - Register Now
Non-Members - Join Now before registering

Non-Member Pricing

Full Event $1,599
Single webinar $395