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0:00
Hello, my name is Norman Baylor.
I'm the President and CEO
of Biologics
Consulting Group, Inc.,
a regulatory consulting firm
based in the Washington
DC area in the United States.
I was formerly
the Director of FDA's Office
of Vaccines Research and Review.
This talk is part 1
of a 2-part presentation
on the US
regulatory requirements.
I will discuss in part 1
their considerations
for chemistry, manufacturing,
and controls of vaccine,
commonly called the CMC
section of the regulations.
Dr. Lewis Schrager discussed
the clinical regulatory
considerations in part 2.
0:41
I outlined the presentation.
I will discuss the organization
and function of the Food
and Drug Administration in the US
and the Office of Vaccines
Research and Review,
which is responsible
for the evaluation
and marketing authorization
for vaccines and
related products.
I will also cover the history
and evolution of the regulations
of vaccines
in the United States.
The legal framework
for vaccine regulations,
I'll define what a vaccine
actually is from
a regulatory perspective.
I will discuss
things to consider
in manufacturing of vaccine
under current good
manufacturing practices.
I'll also discuss
preclinical evaluation,
define process validation,
and briefly mention
new technology used
in the developing of
new generation vaccines.
1:32
The Food and Drug
Administration's Center
for Biologics Evaluation
and Research,
commonly called CBER,
is a national regulatory
authority in the United States
responsible
for assuring quality,
safety, and effectiveness,
of all human medical products
including vaccines
for human use.
Vaccines are
evaluated in CBER's
Office of Vaccines
Research Review.
The Office of Vaccines
Research Review is composed
of two laboratory-based
research divisions,
the Division of
Bacterial, Parasitic
and Allergenic Products,
and the Division
of Viral Products.
And there is also
an applications division
commonly called
the Division of Vaccines
and Related
Products Applications
where the clinical review
of vaccine applications occurs.
