[Michlib-l] Shifting Landscapes tonight: The Vaccine Approval Process

[Thomas Trahey]

    Mason County District Library and Abondia Center now turn to the
process for approving vaccines in the public lecture series Shifting
Landscapes on Monday November 8, with Vaccines: How Good is the Science? at
7-8:30 pm at the Ludington Center for Arts, and on Zoom, featuring John
Quiring, Ph.D. in Mathematics and Biostatistics.

    Science is the second topic in the Shifting Landscapes series. The
2021-2022 series is exploring six areas of our lives that have been
reshaped by or during the Covid-19 epidemic and the many events that have
occurred in the past 20 months.

    For over 45 years, John Quiring has been a consultant to the companies
which make submissions to the Food and Drug Administration through his
company Abond CRO, Inc. He has directed the clinical study design, data
collection, statistical analysis and report preparation for over 80 drugs
and devices that have obtained FDA approval.

    John Quiring will present the science behind the approval of products
that are regulated by the FDA. The overall general clinical data
requirements which form the basis of a NDA (New Drug Approval) submission
will be described. Examples taken from the Pfizer-BioNTech COVID-19 vaccine
FDA submission will be used to illustrate the scientific basis needed for
product approval.

    In asking questions about the nature of science, vaccines, and the
course of the pandemic, Shifting Landscapes’ series hopes to address
questions on people’s minds. And it hopes the information also helps them
get more from news sources as well as their health professionals and others
about science that matters to them.

    There will be no sessions in December but Shifting Landscapes will
start again January 10 focusing on education, including the 1619 Project
(Jan10), Critical Race Theory (Jan 17), and Teaching Difficult Truths to
Children and Youth (Jan 24).
    Events are free, live or by Zoom. Tickets are not necessary but
registration is helpful. To register: mcdl.pub/sl-register. For information
check the Mason County District Library website: mcdlibrary.org or contact
Thomas Trahey, Mason County District Library at ttrahey at mcdlibrary.org or
Brooke Portmann, director of Abondia Center, at baportmann312 at gmail.com

-- 
Thomas Trahey
Mason County District Library
Head of Circulation
231-843-8465
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://mail3.mcls.org/pipermail/michlib-l/attachments/20211108/312f65b9/attachment.html>