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Dear listeners, I will
give you an explanation of
the ICH S8 topic on the
immune system toxicity.
I'm Jan Willem van der
Laan, and I'm retired from
the Medicines Evaluation
Board in the Netherlands,
where I worked together
with my job in
the National Institute
of Public Health for
more than 40 years on
behalf of the Medicines
Evaluation Board.
In that period, I was
also rapporteur for
the ICH S8 on behalf of the
European Medicines Agency,
which was the very last
in the second phase of
the process finalizing
the document
on behalf of the regulators.
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The outline will be
that I will first
introduce are the most
important aspects
of the human immune system.
Furthermore, some
discussions that we had in
the ICH on preparing
the guideline,
and then the guideline itself.
When the guideline
was finished in 2008,
we recently discussed
the possibility of the revision,
which is my own part,
and then we came
to the conclusion.
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The human immune system
is well distributed
over the body.
You see the main
important organs
such as the thymus, the spleen,
and the bone marrow, as well as
the additional lymph nodes in
the tonsils spread
over the body.
That makes the system
very fluid, and
the cells are traveling in the
body among these elements.
